Lynzparza’s new tablet formulation gets FDA approval, expanded indication
WILMINGTON, Del. — AstaZeneca and Merck’s Lynzparza (olaparib) tablets were approved by the Food and Drug Administration, as well as given an expanded indication by the regulatory agency.
The tablets are approved as a maintenance treatment of adult patients with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status. Additionally, they were approved for use twice daily, as opposed to the eight-a-day regimen required of Lynzparza’s capsule formulation.
The drug also is now indicated for use in adult patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. The patients for this indication are selected for treatment base on an FDA-approved companion diagnostic.
“Physicians have almost three years of clinical experience with Lynsparza on the market and we are now pleased to bring this important medicine, in a new tablet formulation, to a broader group of women,” AstraZeneca EVP global medicines development and chief medical officer Sean Bohen said. “Today’s approvals validate more than 10 years of dedicated research behind Lynzparza, the world’s first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings. It builds on our recently-announced collaboration with Merck, which aims to further increase the number of treatment options available to patients.”
Diplomat dispensing Mavyret
FLINT, Mich. — Diplomat Pharmacy is dispensing a newly approved treatment for chronic hepatitis C. The company on Friday announced that it is now dispensing AbbVie’s Mavyret (glecaprevir and pibrentasvir) tablets.
The drug is indicated to treat patients with all major genotypes of chronic hepatitis C infection with cirrhosis or with compensated cirrhosis. It also is also indicated for adults with Genotype 1 infection who previously have been treated with a regimen containing an NS5A inhibitor or an NS3/4A protease inhibitor (but not both).
“We are proud to expand upon Diplomat’s therapy offerings to patients who have been diagnosed with chronic hepatitis C,” said Joel Saban, president of Diplomat. “This valuable treatment option gives more patients the possibility of a life without this serious disease.”
FDA approves Pfizer’s leukemia drug Besponsa
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug from Pfizer, Besponsa (inotuzumab ozogamicin). The drug is indicated to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, or ALL.
"For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "These patients have few treatments available and today's approval provides a new, targeted treatment option."
B-cell precursor ALL is a rapidly progressing type of cancer in which a patient’s bone marrow makes too many of an immature type of white blood cell. The National Cancer Institute estimates that roughly 5,970 people will be diagnosed with it this year, and that 1,440 will die from the illness.
“Besponsa will help address a significant need for new treatment options in B-cell acute lymphoblastic leukemia, and may help more patients reach stem cell transplant, which provides the best chance for long term remission,” Pfizer Oncology global president Liz Barrett said. “We’re proud to build on our continued commitment to patients with hematologic malignancies, and will continue our work to find new treatments in acute lymphoblastic leukemia and other blood cancers.”