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.
Eli Lilly and Co. and ARMO BioSciences Inc. announced a definitive agreement for Lilly to acquire ARMO for $50 per share, or approximately $1.6 billion, in an all-cash transaction.
FDA approved Kymriah (tisagenlecleucel) suspension for intravenous infusion for its second indication – the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
The FDA granted regular approval to Tafinlar (dabrafenib) and Mekinist (trametinib) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node, following complete resection.
