FDA approved Gozellix (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), a next-generation PSMA-PET imaging agent for prostate cancer.
FDA granted traditional approval to Merck’s pembrolizumab (Keytruda) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1).
FDA granted Orphan Drug designation to rhenium obisbemeda (186Re) for the treatment of leptomeningeal metastases in patients with lung cancer.
B-cell acute lymphoblastic leukemia is a common type of ALL in adults.
The phase III VERIFY trial, in which phlebotomy-dependent patients with polycythemia vera were randomized to treatment with either rusfertide (PTG-300) or placebo, as an add-on to standard of care treatment, met its primary endpoint of proportion of patients achieving response.
FDA approved Tevimbra (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (≥1).
As oncology enters a new era of precision medicine, the Food and Drug Administration’s evolving biomarker strategy aims to ensure that life-saving therapies are tailored to individual patient needs, fostering safer and more effective treatments. Historically, therapies were approved with broad indications based on overall efficacy, even when outcomes for biomarker-positive and -negative patients were... […]
Former CDER Director Patrizia Cavazzoni named Pfizer chief medical officer, executive vice president
Patrizia Cavazzoni will rejoin Pfizer Inc. as chief medical officer and executive vice president.
FDA accepted for review the resubmission of the Regeneron Pharmaceuticals, Inc.’s Biologics License Application for Ordspono (odronextamab) in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy. The target action date for the FDA decision is July 30.
FDA accepted Bristol Myers Squibb’s supplemental biologics license application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
