EP. 3: FDA Accepts sNDAs for Encorafenib and Binimetinib for BRAF V600-Mutated NSCLCApril 4th 2023
Results from the phase 2 PHAROS trial of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic non–small cell lung cancer has led the FDA to accept supplemental new drug applications for the agents. Further data will be presented at an upcoming medical meeting.
EP. 4: FDA Accepts BLA of HLX02 for Patients With HER2-Expressing CancersApril 5th 2023
Multiple trials and techniques have evaluated treatment with HLX02 compared with trastuzumab. Now, the FDA has accepted the biologics license application HLX02 for patients with HER2-overexpressing metastatic breast cancer, breast cancer, gastric cancer, and gastroesophageal junction adenocarcinoma.
EP. 8: FDA Halts Phase 1 Study MT-0169 Due to Unacceptable ToxicityApril 12th 2023
Multiple cases of unacceptable toxicity requiring dose reductions have occurred in a phase 1 study of MT-0169 in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma. The FDA has placed a partial clinical hold on the study
EP. 9: FDA Considers Pembrolizumab/Chemotherapy for Approval in Advanced Gastric/GEJ CancerApril 13th 2023
KEYNOTE-859 findings are under review by the FDA as the regulatory body considers an approval application for pembrolizumab plus chemotherapy for the treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
EP. 12: FDA Approves Omidubicel for Blood Cancers in Need of TransplantApril 17th 2023
Omidubicel showed encouraging clinical benefit in a phase 3 study vs standard myeloablative umbilical cord blood in patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant. Now, the FDA has approved the agent for this indication.
EP. 14: FDA Grants Fast Track Designation to Botensilimab/Balstilimab for MSS/dMMR mCRC TreatmentApril 18th 2023
The combination of botensilimab and balstilimab is moving down the FDA pipeline and may become an approved treatment for non-microsatellite instability-high and deficient mismatch repair metastatic colorectal cancer in the future.
EP. 17: FDA Type C Meeting Shows Clinical Activity of Darovasertib/Crizotinib in MUMApril 25th 2023
Promising results from a type C meeting with the FDA has led to a phase 2/3 trial of darovasertib and crizotinib being initiated in 2023 for patients with first-line HLA-A2 negative metastatic uveal melanoma.
EP. 19: FDA Places Partial Clinical Hold on Study of FHD-609 in Synovial SarcomaApril 25th 2023
A patient treated with the second highest dose level of FHD-609 had a grade 4 adverse event. Enrollment in the study of the agent in patients with synovial sarcoma or SMARCB-1 deleted tumors has been halted.
EP. 20: FDA's ODAC Votes Yes to Olaparib Combination Being Restricted to BRCAm mCRPCApril 28th 2023
The Oncologic Drugs Advisory Committee has discussed the approval application for olaparib plus abiraterone and prednisone or prednisolone for patients with metastatic castration-resistant prostate cancer and voted on its potential future.