Chris Ryan

The FDA has granted fast track designation to HP518 for androgen receptor–positive triple-negative breast cancer.

Sara M. Tolaney, MD, MPH, discusses the use of HER2-directed therapy in the curative setting for HER2-positive breast cancer.

Hope Rugo, MD, discusses the management of treatment-limiting toxicities in breast cancer, including the use of antibody-drug conjugates and immunotherapy.

The FDA completed an end-of-phase 2 meeting for botensilimab plus balstilimab in relapsed/refractory microsatellite stable colorectal cancer.

Ibrutinib plus venetoclax produced durable complete responses in TP53-mutated mantle cell lymphoma.

TQB2930 was well tolerated and generated responses in HER2-positive advanced breast cancer.

The FDA has placed a partial clinical hold on a trial evaluating seclidemstat plus azacitidine in myelodysplastic syndromes or chronic myelomonocytic leukemia.

IDE937 produced responses in patients with advanced urothelial cancer or non–small cell lung cancer harboring MTAP deletions.

Moleculin Biotech completed an end-of-phase 2 meeting with the FDA regarding the investigation of annamycin plus cytarabine in acute myeloid leukemia.

Fianlimab plus cemiplimab produced durable responses in heavily pretreated advanced clear cell renal cell carcinoma.

Health Canada has approved osimertinib/chemotherapy for advanced non–small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.

SLS009 has been granted orphan drug designation by the EMA for the treatment of patients with acute myeloid leukemia.

Curium has submitted an NDA to the FDA for its formulation of lutetium Lu 177 dotatate for SSTR-positive gastroenteropancreatic neuroendocrine tumors.

The FDA has granted fast track designation to OBX-115 for advanced melanoma that is refractory to or relapsed after immune checkpoint inhibitors.

Elevar Therapeutics plans to resubmit a new drug application for rivoceranib plus camrelizumab for first-line unresectable hepatocellular carcinoma.

Pembrolizumab plus lenvatinib generated responses in platinum-sensitive recurrent ovarian cancer.

The FDA has granted fast track designation to BNT324/DB-1311 for metastatic castration-resistant prostate cancer.

The FDA has granted fast track designation to ADI-270 for advanced clear cell renal cell carcinoma after an immune checkpoint inhibitor and VEGF inhibitor.

First-line tiragolumab plus atezolizumab and chemotherapy failed to improve survival in advanced nonsquamous non–small cell lung cancer.

The FDA has received a biologics license application resubmission for cosibelimab in locally advanced or metastatic cutaneous squamous cell carcinoma.

Pembrolizumab plus bevacizumab and CAPOX produced responses in pMMR/MSS metastatic colorectal cancer with high immune infiltrate.

The FDA has approved a companion diagnostic for niraparib plus abiraterone acetate in BRCA-mutated metastatic castration-resistant prostate cancer.

Lunresertib plus FOLFIRI was safe and produced responses in advanced gastrointestinal tumors harboring CCNE1 amplifications or FBXW7 alterations.

The FDA has modified the risk evaluation and mitigation strategies for CAR T-cell therapies approved for hematologic malignancies.

The FDA has issued a complete response letter to the BLA for patritumab deruxtecan in pretreated advanced EGFR-mutated non–small cell lung cancer.

China’s NMPA approved toripalimab plus nab-paclitaxel for the first-line treatment of recurrent or metastatic triple-negative breast cancer.

Adjuvant durvalumab did not improve disease-free survival in resected, early-stage non–small cell lung cancer with a PD-L1 expression 25% or more.

The FDA has approved crovalimab for patients 13 years of age and older with paroxysmal nocturnal hemoglobinuria and a body weight of at least 40 kg.

Trilaciclib plus chemotherapy failed to improve overall survival in metastatic triple-negative breast cancer.

The European Commission has approved fruquintinib for select patients with pretreated metastatic colorectal cancer.