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.Â
FDA cleared the LTZ Therapeutics’s Investigational New Drug application for LTZ-301, a first-in-class myeloid engager immunotherapy intended to treat relapsed or refractory non-Hodgkin lymphoma.
Cedars-Sinai performed the first robot-assisted microsurgical head-and-neck cancer reconstructive surgery in the United States after the robot device received FDA approval for the procedure.
FDA granted priority review to Boehringer Ingelheim’s new drug application for BI 1810631 (zongertinib) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have HER2 mutations and who have received prior systemic therapy.
Earlier this week, Robert F. Kennedy Jr. was confirmed as secretary of Health and Human Services amid many resignations at federal health agencies and cancellations of NIH and NCAB meetings. All of this happened at a time when the Trump administration is reportedly preparing to fire thousands of HHS workers.
FDA approved Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
