The CHMP adopted two positive opinions recommending European Commission approval of:
- REVLIMID in combination with bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma who are not eligible for transplant
- IMNOVID in combination with bortezomib and dexamethasone (PVd), for adult patients with multiple myeloma, who have received at least one prior treatment regimen including lenalidomide
SUMMIT, NJ, USA I March 29, 2019 I Celgene Corporation (NASDAQ:CELG), today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for two triplet regimens based on Celgene’s proprietary IMiD® medications, REVLIMID (lenalidomide) and IMNOVID (pomalidomide).
The CHMP recommended approval of an expanded indication of REVLIMID as combination therapy with bortezomib and dexamethasone (RVd) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
The committee also recommended approval of IMNOVID in combination with bortezomib and dexamethasone (PVd), for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months.
“The CHMP positive opinions for our IMiD combinations, RVd and PVd represent very good news for patients with multiple myeloma in Europe,” said Nadim Ahmed, President, Hematology/Oncology for Celgene. “We look forward to potential EMA approvals, which would make these new triplet regimens available to patients, as we aim to improve patient outcomes across multiple stages of their disease.”
The CHMP positive opinion for REVLIMID was based on the data from SWOG S0777, a phase 3 trial evaluating the triplet combination of REVLIMID, bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma, without an intent for immediate autologous stem cell transplant (ASCT).1 Results from SWOG S0777 showed statistically significant progression-free (PFS) and overall survival improvements in patients treated with RVd compared to those treated with REVLIMID and dexamethasone alone (Rd). The choice of treatment in a first-line therapy setting is important2 as patients progressively become less responsive to therapy and experience shorter periods of remission at later lines of treatment.3
The CHMP positive opinion for PVd was based on the data from OPTIMISMM, the first prospective phase 3 trial to evaluate an IMNOVID-based triplet regimen in patients who were previously treated with REVLIMID, and who were, in the majority (70 percent), REVLIMID refractory.4 This patient population represents a growing unmet medical need for which new treatment options are necessary. Results from OPTIMISMM showed that patients receiving PVd achieved a significantly longer PFS than those in the Vd treatment arm.
REVLIMID in combination with bortezomib and dexamethasone and IMNOVID in combination with bortezomib and dexamethasone are not approved for any use in any country.
About Celgene’s Immunomodulatory Drugs
IMiD® agents are Celgene’s proprietary small molecule, orally available compounds for the treatment of some blood cancers. IMiD agents are hypothesized to have multiple mechanisms of action. They have been found to increase activation and proliferation of T cells, and proliferation of the IL-2 protein and activity of CD8+ effector T cells. IMiD agents have also been found to affect the stimulation and expression of natural killer (NK) cells, working within the environment of the cell to stimulate the immune system to attack the cancer cells, as well as attack the cancer cells directly. In addition to immunomodulatory properties, IMiD agents are hypothesized to have tumoricidal and antiangiogenic activity. Celgene’s portfolio of IMiD agents have become a foundation of multiple myeloma research, with a growing number of studies exploring these compounds as combination partners across a range of settings of the disease.
About Multiple Myeloma
Multiple myeloma is a life-threatening blood cancer that is characterized by tumor proliferation and suppression of the immune system.5 It is a rare but deadly disease—around 42,000 people are diagnosed with multiple myeloma in Europe, and approximately 26,000 people die from the disease each year.6 The typical multiple myeloma disease course includes periods of symptomatic myeloma followed by periods of remission, and eventually, the disease becomes refractory (nonresponsive).
About SWOG S0777
SWOG S0777 is a randomized, open-label, multicentre, phase 3 study aiming to evaluate the efficacy and safety of RVd compared to Rd in treating patients with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT).
SWOG S0777 recruited 525 patients with symptomatic and measurable ndMM aged 18 years and older. Patients were randomly assigned (1:1) to receive either an initial treatment of lenalidomide with bortezomib and dexamethasone (RVd group) or lenalidomide and dexamethasone alone (Rd group). Randomization was stratified based on International Staging System stage (I, II, or III) and intent to transplant (yes versus no). The RVd regimen was given as eight 21-day cycles. Bortezomib was given at 1.3 mg/m2 intravenously on days 1, 4, 8, and 11, combined with oral lenalidomide 25 mg daily on days 1-14 plus oral dexamethasone 20 mg daily on days 1, 2, 4, 5, 8, 9, 11, and 12. The Rd regimen was given as six 28-day cycles. The standard Rd regimen consisted of 25 mg oral lenalidomide once a day for days 1-21 plus 40 mg oral dexamethasone once a day on days 1, 8, 15, and 22.
Results from SWOG S07771 showed that median progression-free survival (PFS) was significantly improved in patients receiving RVd compared to those receiving REVLIMID and dexamethasone (Rd) alone (42 months versus 30 months; HR 0.76, 95% CI 0.62-0.94; P=0.01). Median overall survival was also significantly improved in patients receiving RVd compared to those receiving Rd (89 months versus 67 months; HR 0.72, 95% CI 0.56–0.94; P=0.013). The rates of overall and complete response were higher in those receiving RVd compared to Rd (overall response: 82% RVd vs 72% Rd; complete response: 16% RVd vs 8% Rd). The safety of RVd was also consistent with the well-established safety profiles of each drug in the triplet therapy.7,8
Upon completion of induction, all patients received ongoing maintenance with 25 mg oral lenalidomide once a day for 21 days plus 40 mg oral dexamethasone once a day for days 1, 8, 15, and 22 of each 28-day cycle.
About OPTIMISMM
OPTIMISMM is the first phase 3 trial designed to compare the safety and efficacy of PVd versus Vd, as an early line of therapy in patients with relapsed and refractory multiple myeloma (with 1-3 prior regimens of therapy) and prior REVLIMID-exposure, including REVLIMID-refractory patients.
The multi-center, international, open-label, randomized phase 3 clinical trial included 559 patients (281 patients in the PVd arm and 278 in the Vd arm). Demographic, baseline, and prior disease characteristics were generally well balanced between the two treatment arms. The median number of prior lines of therapy was two, while more than one third had one prior line of treatment (40% across both treatment arms). All patients had prior treatment with REVLIMID® with the majority being REVLIMID refractory (71 percent in the PVd arm vs 69 percent in the Vd arm) and 70 percent vs 66 percent, respectively, were refractory to their last treatment. Median follow-up was 16 months.
Results from OPTIMISMM4 showed that patients receiving PVd achieved a significantly longer PFS than those in the Vd treatment arm (11.20 months vs. 7.10 months, respectively [P= < .0001, HR 0.61; 95% CI: (0.49-0.77)]), reducing the risk of disease progression or death by 39% in the PVd arm. In an exploratory sub-group analysis of patients with one prior line of therapy, median progression-free survival with PVd was 20.73 months vs 11.63 months with Vd (HR 0.54; p=0·0027). In these patients, the benefit of PVd was independent of whether they were refractory or non-refractory to prior therapy with lenalidomide. The safety of PVd was consistent with the well-established safety profiles of each drug in the triplet therapy.7
Patients were stratified based on age (≤ 75 years old vs > 75 years old), number of prior anti-myeloma regimens (1 vs. > 1), and β2-microglobulin levels (< 3.5 mg/L vs ≥ 3.5 to ≤ 5.5 mg/L vs > 5.5 mg/L). Patients were randomized 1:1 to receive PVd or Vd. In 21-day cycles, patients received
IMNOVID 4 mg/d on days 1-14 (PVd arm only); bortezomib 1.3 mg/m2 on days 1, 4, 8 and 11 of cycles 1-8 and on days 1 and 8 of cycles 9 and beyond; and dexamethasone 20 mg/d (10 mg if aged > 75 years) on the days of and after receiving bortezomib treatment.
About REVLIMID®
REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM)
REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT)
REVLIMID® is indicated for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities
REVLIMID® is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib
REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials
About IMNOVID® (pomalidomide)
IMNOVID® in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. It belongs to a group of drugs called immunomodulatory drugs (IMiDs®).
IMNOVID, which is marketed under trade name POMALYST® in the US, was first approved for use in the US in 2013 in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Imnovid in combination with bortezomib and dexamethasone is not approved for use in United States.
It was approved in the EU in 2013, in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
It is also approved in a total of 66 countries worldwide including Australia, Canada, Japan and Switzerland for use in combination with dexamethasone for similar indications to US and EU.
About POMALYST
Indication
POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
ABOUT CELGENE
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company’s website at www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
References:
| ___________________________ |
| 1 Durie BG, Hoering A, Abidi MH, et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. Lancet. 2017 Feb 4;389(10068):519-527. |
| 2 Liwing J, Uttervall K, Lund J, et al. Improved survival in myeloma patients: starting to close in on the gap between elderly patients and a matched normal population. Br J Haematol. 2014 Mar;164(5):684-93. |
| 3 Kumar SK, Therneau TM, Gertz MA, et al. Clinical course of patients with relapsed multiple myeloma. Mayo Clin Proc. 2004 Jul;79(7):867–874. |
| 4 Richardson P, Rocafiguera A, Beksac M, et al. OPTIMISMM: Phase 3 trial of pomalidomide, bortezomib, and low‐dose dexamethasone vs bortezomib and low-dose dexamethasone in lenalidomide-exposed patients with relapsed or refractory multiple myeloma. Presented at: American Society of Clinical Oncology Annual Meeting; June 1, 2018; Chicago, IL. |
| 5 Palumbo A and Anderson K. Multiple myeloma. N Engl J Med. 2011;364:1046-1060. |
| 6 European Cancer Information System. Estimates of cancer incidence and mortality in 2018, for all countries. Available at: https://ecis.jrc.ec.europa.eu/explorer.php. Accessed March 2019. |
| 7 Berenson JR, Jagannath S, Barologie B, et al. Safety of prolonged therapy with bortezomib in relapsed or refractory multiple myeloma. Cancer. 2005:104(10):2141-8. |
| 8 European Medicines Agency. REVLIMID summary of product characteristics, 2009. Updated 23/08/2018. |
SOURCE: Celgene
Post Views: 25
The CHMP adopted two positive opinions recommending European Commission approval of:
- REVLIMID in combination with bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma who are not eligible for transplant
- IMNOVID in combination with bortezomib and dexamethasone (PVd), for adult patients with multiple myeloma, who have received at least one prior treatment regimen including lenalidomide
SUMMIT, NJ, USA I March 29, 2019 I Celgene Corporation (NASDAQ:CELG), today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for two triplet regimens based on Celgene’s proprietary IMiD® medications, REVLIMID (lenalidomide) and IMNOVID (pomalidomide).
The CHMP recommended approval of an expanded indication of REVLIMID as combination therapy with bortezomib and dexamethasone (RVd) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
The committee also recommended approval of IMNOVID in combination with bortezomib and dexamethasone (PVd), for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months.
“The CHMP positive opinions for our IMiD combinations, RVd and PVd represent very good news for patients with multiple myeloma in Europe,” said Nadim Ahmed, President, Hematology/Oncology for Celgene. “We look forward to potential EMA approvals, which would make these new triplet regimens available to patients, as we aim to improve patient outcomes across multiple stages of their disease.”
The CHMP positive opinion for REVLIMID was based on the data from SWOG S0777, a phase 3 trial evaluating the triplet combination of REVLIMID, bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma, without an intent for immediate autologous stem cell transplant (ASCT).1 Results from SWOG S0777 showed statistically significant progression-free (PFS) and overall survival improvements in patients treated with RVd compared to those treated with REVLIMID and dexamethasone alone (Rd). The choice of treatment in a first-line therapy setting is important2 as patients progressively become less responsive to therapy and experience shorter periods of remission at later lines of treatment.3
The CHMP positive opinion for PVd was based on the data from OPTIMISMM, the first prospective phase 3 trial to evaluate an IMNOVID-based triplet regimen in patients who were previously treated with REVLIMID, and who were, in the majority (70 percent), REVLIMID refractory.4 This patient population represents a growing unmet medical need for which new treatment options are necessary. Results from OPTIMISMM showed that patients receiving PVd achieved a significantly longer PFS than those in the Vd treatment arm.
REVLIMID in combination with bortezomib and dexamethasone and IMNOVID in combination with bortezomib and dexamethasone are not approved for any use in any country.
About Celgene’s Immunomodulatory Drugs
IMiD® agents are Celgene’s proprietary small molecule, orally available compounds for the treatment of some blood cancers. IMiD agents are hypothesized to have multiple mechanisms of action. They have been found to increase activation and proliferation of T cells, and proliferation of the IL-2 protein and activity of CD8+ effector T cells. IMiD agents have also been found to affect the stimulation and expression of natural killer (NK) cells, working within the environment of the cell to stimulate the immune system to attack the cancer cells, as well as attack the cancer cells directly. In addition to immunomodulatory properties, IMiD agents are hypothesized to have tumoricidal and antiangiogenic activity. Celgene’s portfolio of IMiD agents have become a foundation of multiple myeloma research, with a growing number of studies exploring these compounds as combination partners across a range of settings of the disease.
About Multiple Myeloma
Multiple myeloma is a life-threatening blood cancer that is characterized by tumor proliferation and suppression of the immune system.5 It is a rare but deadly disease—around 42,000 people are diagnosed with multiple myeloma in Europe, and approximately 26,000 people die from the disease each year.6 The typical multiple myeloma disease course includes periods of symptomatic myeloma followed by periods of remission, and eventually, the disease becomes refractory (nonresponsive).
About SWOG S0777
SWOG S0777 is a randomized, open-label, multicentre, phase 3 study aiming to evaluate the efficacy and safety of RVd compared to Rd in treating patients with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT).
SWOG S0777 recruited 525 patients with symptomatic and measurable ndMM aged 18 years and older. Patients were randomly assigned (1:1) to receive either an initial treatment of lenalidomide with bortezomib and dexamethasone (RVd group) or lenalidomide and dexamethasone alone (Rd group). Randomization was stratified based on International Staging System stage (I, II, or III) and intent to transplant (yes versus no). The RVd regimen was given as eight 21-day cycles. Bortezomib was given at 1.3 mg/m2 intravenously on days 1, 4, 8, and 11, combined with oral lenalidomide 25 mg daily on days 1-14 plus oral dexamethasone 20 mg daily on days 1, 2, 4, 5, 8, 9, 11, and 12. The Rd regimen was given as six 28-day cycles. The standard Rd regimen consisted of 25 mg oral lenalidomide once a day for days 1-21 plus 40 mg oral dexamethasone once a day on days 1, 8, 15, and 22.
Results from SWOG S07771 showed that median progression-free survival (PFS) was significantly improved in patients receiving RVd compared to those receiving REVLIMID and dexamethasone (Rd) alone (42 months versus 30 months; HR 0.76, 95% CI 0.62-0.94; P=0.01). Median overall survival was also significantly improved in patients receiving RVd compared to those receiving Rd (89 months versus 67 months; HR 0.72, 95% CI 0.56–0.94; P=0.013). The rates of overall and complete response were higher in those receiving RVd compared to Rd (overall response: 82% RVd vs 72% Rd; complete response: 16% RVd vs 8% Rd). The safety of RVd was also consistent with the well-established safety profiles of each drug in the triplet therapy.7,8
Upon completion of induction, all patients received ongoing maintenance with 25 mg oral lenalidomide once a day for 21 days plus 40 mg oral dexamethasone once a day for days 1, 8, 15, and 22 of each 28-day cycle.
About OPTIMISMM
OPTIMISMM is the first phase 3 trial designed to compare the safety and efficacy of PVd versus Vd, as an early line of therapy in patients with relapsed and refractory multiple myeloma (with 1-3 prior regimens of therapy) and prior REVLIMID-exposure, including REVLIMID-refractory patients.
The multi-center, international, open-label, randomized phase 3 clinical trial included 559 patients (281 patients in the PVd arm and 278 in the Vd arm). Demographic, baseline, and prior disease characteristics were generally well balanced between the two treatment arms. The median number of prior lines of therapy was two, while more than one third had one prior line of treatment (40% across both treatment arms). All patients had prior treatment with REVLIMID® with the majority being REVLIMID refractory (71 percent in the PVd arm vs 69 percent in the Vd arm) and 70 percent vs 66 percent, respectively, were refractory to their last treatment. Median follow-up was 16 months.
Results from OPTIMISMM4 showed that patients receiving PVd achieved a significantly longer PFS than those in the Vd treatment arm (11.20 months vs. 7.10 months, respectively [P= < .0001, HR 0.61; 95% CI: (0.49-0.77)]), reducing the risk of disease progression or death by 39% in the PVd arm. In an exploratory sub-group analysis of patients with one prior line of therapy, median progression-free survival with PVd was 20.73 months vs 11.63 months with Vd (HR 0.54; p=0·0027). In these patients, the benefit of PVd was independent of whether they were refractory or non-refractory to prior therapy with lenalidomide. The safety of PVd was consistent with the well-established safety profiles of each drug in the triplet therapy.7
Patients were stratified based on age (≤ 75 years old vs > 75 years old), number of prior anti-myeloma regimens (1 vs. > 1), and β2-microglobulin levels (< 3.5 mg/L vs ≥ 3.5 to ≤ 5.5 mg/L vs > 5.5 mg/L). Patients were randomized 1:1 to receive PVd or Vd. In 21-day cycles, patients received
IMNOVID 4 mg/d on days 1-14 (PVd arm only); bortezomib 1.3 mg/m2 on days 1, 4, 8 and 11 of cycles 1-8 and on days 1 and 8 of cycles 9 and beyond; and dexamethasone 20 mg/d (10 mg if aged > 75 years) on the days of and after receiving bortezomib treatment.
About REVLIMID®
REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM)
REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT)
REVLIMID® is indicated for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities
REVLIMID® is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib
REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials
About IMNOVID® (pomalidomide)
IMNOVID® in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. It belongs to a group of drugs called immunomodulatory drugs (IMiDs®).
IMNOVID, which is marketed under trade name POMALYST® in the US, was first approved for use in the US in 2013 in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Imnovid in combination with bortezomib and dexamethasone is not approved for use in United States.
It was approved in the EU in 2013, in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
It is also approved in a total of 66 countries worldwide including Australia, Canada, Japan and Switzerland for use in combination with dexamethasone for similar indications to US and EU.
About POMALYST
Indication
POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
ABOUT CELGENE
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company’s website at www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
References:
| ___________________________ |
| 1 Durie BG, Hoering A, Abidi MH, et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. Lancet. 2017 Feb 4;389(10068):519-527. |
| 2 Liwing J, Uttervall K, Lund J, et al. Improved survival in myeloma patients: starting to close in on the gap between elderly patients and a matched normal population. Br J Haematol. 2014 Mar;164(5):684-93. |
| 3 Kumar SK, Therneau TM, Gertz MA, et al. Clinical course of patients with relapsed multiple myeloma. Mayo Clin Proc. 2004 Jul;79(7):867–874. |
| 4 Richardson P, Rocafiguera A, Beksac M, et al. OPTIMISMM: Phase 3 trial of pomalidomide, bortezomib, and low‐dose dexamethasone vs bortezomib and low-dose dexamethasone in lenalidomide-exposed patients with relapsed or refractory multiple myeloma. Presented at: American Society of Clinical Oncology Annual Meeting; June 1, 2018; Chicago, IL. |
| 5 Palumbo A and Anderson K. Multiple myeloma. N Engl J Med. 2011;364:1046-1060. |
| 6 European Cancer Information System. Estimates of cancer incidence and mortality in 2018, for all countries. Available at: https://ecis.jrc.ec.europa.eu/explorer.php. Accessed March 2019. |
| 7 Berenson JR, Jagannath S, Barologie B, et al. Safety of prolonged therapy with bortezomib in relapsed or refractory multiple myeloma. Cancer. 2005:104(10):2141-8. |
| 8 European Medicines Agency. REVLIMID summary of product characteristics, 2009. Updated 23/08/2018. |
SOURCE: Celgene
Post Views: 25
