FDA has approved, under priority review, Venclexta (venetoclax tablets) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy.
FDA approved Fulphila (pegfilgrastim-jmdb) as a biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
FDA, EMA accept application for talazoparib in metastatic breast cancer with inherited BRCA mutation
Pfizer Inc. said FDA has accepted for filing and granted Priority Review designation to the company's New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.
Loxo Oncology Inc. said FDA has accepted the company's New Drug Application and granted Priority Review for larotrectinib (LOXO-101) for adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.
The FDA has approved Doptelet (avatrombopag) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure.
Foundation Medicine Inc. and Merck announced a collaboration to develop companion diagnostic tests for use with Keytruda (pembrolizumab), Merck's anti-PD-1 therapy and the first approved immunotherapy for microsatellite instability high or mismatch repair deficient solid tumors.
The FDA approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.
FDA has approved Darzalex (daratumumab) in combination with Velcade (bortezomib), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The European Medicines Agency has approved LYNPARZA (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status.
FDA has accepted the company's supplemental Biologics License Application and granted Priority Review for Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin, for the initial treatment of people with metastatic non-squamous non-small cell lung cancer.
