Pharmaceuticals, Biotechnology and Life Sciences
The European Medicines Agency (EMA) has validated Bristol Myers Squibb-s type II variation application for Opdivo (nivolumab) in combination with chemotherapy for the neoadjuvant treatment of patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC), based on results from the CheckMate -816 trial.
Takeda’s Alunbrig long-Term results from the phase 3 ALTA 1L trial established Alunbrig as a superior first-line treatment compared to crizotinib for people with ALK+ metastatic NSCLC, including those with brain metastases.
Teva Pharmaceuticals USA, Inc., an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the autoinjector device for AJOVY® (fremanezumab-vfrm) injection is now available in the U.S.
Mirati Therapeutics and Bristol-Myers Squibb will work together on evaluating the combination of sitravatinib and nivolumab (OPDIVO), in Mirati’s planned Phase 3 trial in second line non-small cell lung cancer (NSCLC) patients who have progressed following treatment with a platinum-based regimen and a checkpoint inhibitor.
Bristol-Myers Squibb (BMS) and Calithera Biosciences have expanded their existing collaboration to evaluate BMS’s Opdivo in combination with Calithera’s CB-839 in patients with non-small cell lung cancer (NSCLC) and melanoma.
U.S. Food and Drug Administration (FDA) has granted regular approval to AstraZeneca’s osimertinib (Tagrisso), for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
US Food and Drug Administration (FDA) has accepted Novartis’s supplemental New Drug Application (sNDA) for filing, and granted Priority Review for the expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Eli Lilly has gotten the U.S. Food and Drug Administration (FDA) approval for cancer drug Portrazza, which comes in a form of injection for intravenous use, 800 mg/50 mL, in combination with gemcitabine and cisplatin.
Eli Lilly and Merck are moving on with an existing oncology clinical trial collaboration to evaluate the safety and efficacy of the combination of Lilly’s Almita (pemetrexed for injection) and Merck’s Keytruda (pembrolizumab) in a pivotal Phase III study in first-line nonsquamous non-small cell lung cancer (NSCLC).