Brian Park, PharmD

The FDA has approved Reblozyl® (luspatercept–aamt; Bristol-Myers Squibb and Acceleron) for the treatment of anemia in adults with lower-risk myelodysplastic syndromes.

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).


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 (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.

Lurbinectedin is a selective inhibitor of trans-activated RNA polymerase II transcription.

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.

The US FDA has approved olaparib for the maintenance treatment of some adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma.

Approval was based on data from a phase 2 trial that evaluated the safety and efficacy Brukinsa in 86 patients with MCL.

The FDA has approved Ziextenzo (pegfilgrastim-bmez; Sandoz), a biosimilar to Neulasta.