BridgeBio Pharma and Bristol Myers Squibb announced an exclusive license to develop and commercialize BBP-398, an SHP2 inhibitor, in oncology.
Cullinan Oncology Inc. and Taiho Pharmaceutical Co., Ltd. announced an agreement through which Taiho will acquire Cullinan Pearl Corp. and co-develop and co-commercialize Cullinan Oncology’s lead program, CLN-081/TAS6417, an orally available, differentiated, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations, while sparing cells expressing wild-type EGFR in non-small cell lung cancer.
Enhertu (fam-trastuzumab deruxtecan-nxki) received FDA regular approval for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy.
FDA granted Priority Review for Imfinzi (durvalumab) in combination with standard-of-care chemotherapy, for patients with locally advanced or metastatic biliary tract cancer (BTC).
FDA granted Fast Track designation to HM43239, an oral, myeloid kinome inhibitor, for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with FLT3 mutation.
The European Commission approved Kymriah (tisagenlecleucel), a CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The European Commission has approved the use of Cabometyx (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma, refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy.
Myriad Genetics Inc. expanded its partnership with Intermountain Precision Genomics to add a new liquid biopsy therapy selection test to its oncology portfolio.
Aadi Bioscience Inc. has received a product-specific, permanent J-code for Fyarro (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion and recommended granting marketing authorization for Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer harboring alterations leading to mesenchymal-epithelial-transition factor gene exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
