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.
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.
Tempus AI Inc. and Stemline Therapeutics Inc. announced a new collaboration. The two companies will leverage Next—Tempus’ AI-enabled care pathway intelligence platform—to help clinicians determine when an ESR1 test may be appropriate.
DeepHealth and ConcertAI’s TeraRecon announced a strategic collaboration to integrate certain capabilities to advance imaging tools and the radiology workflow.
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.
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.
FDA approved Gomekli (mirdametinib), a kinase inhibitor from SpringWorks Therapeutics, for adult and pediatric patients two years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection.
The European Commission granted marketing authorization for Removab (catumaxomab), making the drug the only approved drug therapy for malignant ascites for patients living with this debilitating condition across Europe.
Moffitt Cancer Center and 1ST Biotherapeutics are collaborating to accelerating innovative cancer research and clinical development.
