Servier Pharmaceuticals, a leader in hematology, achieves first major milestone in the solid tumor category
Company has grown U.S. oncology business by nearly 20% in the past two years
BOSTON, MA, USA I May 5, 2021 I Servier Pharmaceuticals, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for TIBSOVO (ivosidenib tablets) as a potential treatment for patients with previously treated IDH1-mutated cholangiocarcinoma.
The sNDA was granted Priority Review, which accelerates the review time from 10 months to a goal of 6 months from the day of filing acceptance. Priority Review is typically given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.
“While today is a significant milestone in our company’s history, it is also a beacon of hope for the cholangiocarcinoma patient community,” said David K. Lee, CEO, Servier Pharmaceuticals. “As we continue to expand our oncology leadership presence in the U.S. into the solid tumor space, we remain committed to addressing the critical unmet needs of patients with difficult-to-treat cancers including cholangiocarcinoma.”
The sNDA acceptance is supported by data from the ClarIDHy study, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma. An encore presentation of the data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 4-8, 2021.
“Currently, there are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available for patients with advanced disease,” said Susan Pandya, M.D., Vice President, Clinical Development, Head of Cancer Metabolism Global Development, Servier Pharmaceuticals. “The FDA’s Priority Review is a major milestone for patients. I’d like to acknowledge and thank all the patients, their families and the investigators and research teams who took part in the ClarIDHy study.”
TIBSOVO (ivosidenib tablets) is currently approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML) and for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.
In an effort to meet more patient needs than ever before, Servier Pharmaceuticals has grown by nearly 20% in the past two years. The company will continue to grow its oncology portfolio through new and existing research and development collaborations, potential acquisitions and a new lab opening in 2022.
About Cholangiocarcinoma
Cholangiocarcinoma is a rare, aggressive cancer of the bile ducts within and outside of the liver. IDH1 mutations occur in approximately 13% of cholangiocarcinoma cases and are not associated with prognosis. There are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available in the advanced setting. Gemcitabine-based chemotherapy is often recommended for newly diagnosed advanced or metastatic disease.
About TIBSOVO® (ivosidenib tablets)
TIBSOVO® is indicated for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in:
- Adult patients with newly-diagnosed AML who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
- Adult patients with relapsed or refractory AML.
Please see full Prescribing Information, including Boxed WARNING.
About Servier Pharmaceuticals
Servier Pharmaceuticals, LLC is a commercial-stage company with a passion for innovation and improving the lives of patients, their families and caregivers. A privately held company, Servier has the unique freedom to devote its time and energy toward putting those who require our treatment and care first, with future growth driven by innovation in areas of unmet medical need.
As a growing leader in oncology, Servier is committed to finding solutions that will address today’s challenges. The company’s oncology portfolio of innovative medicines is designed to bring more life-saving treatments to a greater number of patients, across the entire spectrum of disease and in a variety of tumor types.
Servier believes co-creation is fundamental to driving innovation and is actively building alliances, acquisitions, licensing deals and partnerships that bring solutions and accelerate access to therapies. With our commercial expertise, global reach, scientific expertise and commitment to clinical excellence, Servier Pharmaceuticals is dedicated to bringing the promise of tomorrow to the patients that we serve.
More information: www.servier.us
SOURCE: Servier Pharmaceuticals
Post Views: 261
Servier Pharmaceuticals, a leader in hematology, achieves first major milestone in the solid tumor category
Company has grown U.S. oncology business by nearly 20% in the past two years
BOSTON, MA, USA I May 5, 2021 I Servier Pharmaceuticals, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for TIBSOVO (ivosidenib tablets) as a potential treatment for patients with previously treated IDH1-mutated cholangiocarcinoma.
The sNDA was granted Priority Review, which accelerates the review time from 10 months to a goal of 6 months from the day of filing acceptance. Priority Review is typically given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.
“While today is a significant milestone in our company’s history, it is also a beacon of hope for the cholangiocarcinoma patient community,” said David K. Lee, CEO, Servier Pharmaceuticals. “As we continue to expand our oncology leadership presence in the U.S. into the solid tumor space, we remain committed to addressing the critical unmet needs of patients with difficult-to-treat cancers including cholangiocarcinoma.”
The sNDA acceptance is supported by data from the ClarIDHy study, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma. An encore presentation of the data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 4-8, 2021.
“Currently, there are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available for patients with advanced disease,” said Susan Pandya, M.D., Vice President, Clinical Development, Head of Cancer Metabolism Global Development, Servier Pharmaceuticals. “The FDA’s Priority Review is a major milestone for patients. I’d like to acknowledge and thank all the patients, their families and the investigators and research teams who took part in the ClarIDHy study.”
TIBSOVO (ivosidenib tablets) is currently approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML) and for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.
In an effort to meet more patient needs than ever before, Servier Pharmaceuticals has grown by nearly 20% in the past two years. The company will continue to grow its oncology portfolio through new and existing research and development collaborations, potential acquisitions and a new lab opening in 2022.
About Cholangiocarcinoma
Cholangiocarcinoma is a rare, aggressive cancer of the bile ducts within and outside of the liver. IDH1 mutations occur in approximately 13% of cholangiocarcinoma cases and are not associated with prognosis. There are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available in the advanced setting. Gemcitabine-based chemotherapy is often recommended for newly diagnosed advanced or metastatic disease.
About TIBSOVO® (ivosidenib tablets)
TIBSOVO® is indicated for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in:
- Adult patients with newly-diagnosed AML who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
- Adult patients with relapsed or refractory AML.
Please see full Prescribing Information, including Boxed WARNING.
About Servier Pharmaceuticals
Servier Pharmaceuticals, LLC is a commercial-stage company with a passion for innovation and improving the lives of patients, their families and caregivers. A privately held company, Servier has the unique freedom to devote its time and energy toward putting those who require our treatment and care first, with future growth driven by innovation in areas of unmet medical need.
As a growing leader in oncology, Servier is committed to finding solutions that will address today’s challenges. The company’s oncology portfolio of innovative medicines is designed to bring more life-saving treatments to a greater number of patients, across the entire spectrum of disease and in a variety of tumor types.
Servier believes co-creation is fundamental to driving innovation and is actively building alliances, acquisitions, licensing deals and partnerships that bring solutions and accelerate access to therapies. With our commercial expertise, global reach, scientific expertise and commitment to clinical excellence, Servier Pharmaceuticals is dedicated to bringing the promise of tomorrow to the patients that we serve.
More information: www.servier.us
SOURCE: Servier Pharmaceuticals
Post Views: 261
