The FDA has granted Breakthrough Therapy designation to JNJ-6372 (Janssen) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.
The FDA has approved Sarclisa (isatuximab-irfc; Sanofi), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
The Food and Drug Administration has granted Priority Review for the supplemental New Drug Application (sNDA) for brigatinib (Takeda) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC).
Lurbinectedin is a selective inhibitor of trans-activated RNA polymerase II transcription.
The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Tazverik® (tazemetostat; Epizyme) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) who have received at least 2 prior lines of systemic therapy.
The FDA has accepted for Priority Review the New Drug Application (NDA) for tucatinib (Seattle Genetics), in combination with trastuzumab and capecitabine, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least 3 prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting.
The FDA has granted Priority Review to the Biologics License Application (BLA) of belantamab mafodotin (GSK2857916; GlaxoSmithKline) for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
The FDA has approved Ayvakit (avapritinib; Blueprint Medicines Corporation), a tyrosine kinase inhibitor, for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
Results showed that Lynparza had a significantly longer median PFS compared with placebo (7.4 months vs 3.8 months).
Apixaban is a factor Xa inhibitor that will be available in 2.5mg and 5mg tablets.
