TOKYO, Japan I January 18, 2016 I Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) submitted by its U.S. subsidiary Eisai Inc. for Eisai’s in-house developed novel anticancer agent lenvatinib mesylate (generic name, “lenvatinib”) for use in the treatment of advanced or metastatic renal cell carcinoma, and granted the sNDA Priority Review status.
The FDA’s Priority Review designation is assigned to applications for drugs that would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of May 16, 2016, 6 months after the sNDA was submitted. Furthermore, lenvatinib has received a Breakthrough Therapy designation from the FDA. In addition, an application seeking approval for use in the treatment of renal cell carcinoma was submitted in Europe in January 2016, and Eisai intends to discuss further steps regarding submission strategies for this potential indication with the regulatory authorities in Japan as well.
This sNDA was based on a Phase II clinical study (Study 205)*1 that compared the safety and efficacy among three groups including a combination of lenvatinib (18 mg) plus everolimus (5 mg), lenvatinib alone (24 mg) and everolimus alone (10 mg) in unresectable advanced or metastatic renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy. From the results of the study, the group who received the combination of lenvatinib plus everolimus demonstrated a significant extension in progression free survival (PFS), the study’s primary endpoint, compared to the everolimus alone group. Additionally, the lenvatinib alone group demonstrated an extension in PFS compared to the everolimus alone group. Both the lenvatinib plus everolimus group and the lenvatinib alone group showed an improvement in objective response rate compared to the everolimus alone group. The most common treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher were diarrhea, hypertension and fatigue.
The number of patients with kidney cancer in the United States is estimated to be approximately 58,000,*2 and renal cell carcinoma comprises more than 90% of all malignancies of the kidney.*3 For advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical need.
Currently lenvatinib has been launched under the brand name Lenvima(R)in the United States, Japan and Europe for use in the treatment of refractory thyroid cancer*. Eisai is committed to exploring the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer and their families.
*1 Motzer, R, et al. “Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised,
phase 2, open-label, multicentre trial.” The Lancet Oncology, 2015; 16, 1473-1482.
*2 Globocan 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012, http://globocan.iarc.fr/
*3 Eble J.N, ed. Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs. 3rd ed. World Health
Organization Classification of Tumours, vol.7 (IARC, 2004)
SOURCE: Eisai
Post Views: 524
TOKYO, Japan I January 18, 2016 I Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) submitted by its U.S. subsidiary Eisai Inc. for Eisai’s in-house developed novel anticancer agent lenvatinib mesylate (generic name, “lenvatinib”) for use in the treatment of advanced or metastatic renal cell carcinoma, and granted the sNDA Priority Review status.
The FDA’s Priority Review designation is assigned to applications for drugs that would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of May 16, 2016, 6 months after the sNDA was submitted. Furthermore, lenvatinib has received a Breakthrough Therapy designation from the FDA. In addition, an application seeking approval for use in the treatment of renal cell carcinoma was submitted in Europe in January 2016, and Eisai intends to discuss further steps regarding submission strategies for this potential indication with the regulatory authorities in Japan as well.
This sNDA was based on a Phase II clinical study (Study 205)*1 that compared the safety and efficacy among three groups including a combination of lenvatinib (18 mg) plus everolimus (5 mg), lenvatinib alone (24 mg) and everolimus alone (10 mg) in unresectable advanced or metastatic renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy. From the results of the study, the group who received the combination of lenvatinib plus everolimus demonstrated a significant extension in progression free survival (PFS), the study’s primary endpoint, compared to the everolimus alone group. Additionally, the lenvatinib alone group demonstrated an extension in PFS compared to the everolimus alone group. Both the lenvatinib plus everolimus group and the lenvatinib alone group showed an improvement in objective response rate compared to the everolimus alone group. The most common treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher were diarrhea, hypertension and fatigue.
The number of patients with kidney cancer in the United States is estimated to be approximately 58,000,*2 and renal cell carcinoma comprises more than 90% of all malignancies of the kidney.*3 For advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical need.
Currently lenvatinib has been launched under the brand name Lenvima(R)in the United States, Japan and Europe for use in the treatment of refractory thyroid cancer*. Eisai is committed to exploring the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer and their families.
*1 Motzer, R, et al. “Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised,
phase 2, open-label, multicentre trial.” The Lancet Oncology, 2015; 16, 1473-1482.
*2 Globocan 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012, http://globocan.iarc.fr/
*3 Eble J.N, ed. Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs. 3rd ed. World Health
Organization Classification of Tumours, vol.7 (IARC, 2004)
SOURCE: Eisai
Post Views: 524
