Chris Ryan

The FDA accepted a supplemental new drug application to darolutamide plus androgen deprivation therapy for metastatic hormone-sensitive prostate cancer.

The FDA granted an accelerated approval to zanidatamab-hrii for previously treated, unresectable or metastatic HER2-positve biliary tract cancer.

The FDA granted a fast track designation to ALE-P02 for patients with CLDN1-positive squamous solid tumors.

The FDA approved ninlotinib tablets that do not have mealtime restrictions for Ph-positive CML in chronic phase and CML that was previously treated.

The FDA received a biologics license application for datopotamab deruxtecan for previously treated EGFR-mutant non-small cell lung cancer.

The FDA approved obecabtagene autoleucel (obe-cel; Aucatzyl) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The FDA extended the Prescription Drug User Fee Act date for the biologics license application seeking approval of zenocutuzumab for NRG1-positive lung and pancreatic cancer.

The FDA has received a rolling new drug application (NDA) for avutometinib plus defactinib for the treatment of adult patients with recurrent low-grade serous ovarian cancer harboring KRAS mutations who have received at least 1 prior line of systemic therapy.

The pharmaceutical company behind mesylate submitted a new drug application for a ready-to-use 3-month formulation of the drug.

Among evaluable patients with Waldenström macroglobulinemia, the ORR was 77.8% with NX-5948.

The DetermalO identified patients with early-stage triple-negative breast cancer who would benefit from presurgical atezolizumab plus carboplatin and nab-paclitaxel.

The World Health Organization updated their guidelines to include CINtec PLUS Cytology for gynecologic cancer prevention.

The FDA approved amivantamab-vmjw plus chemotherapy for locally advanced or metastatic non–small cell lung cancer (NSCLC) that harbors EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI.

Patients with early-stage triple-negative breast cancer tended to have improved survival with neoadjuvant pembrolizumab plus chemo followed by adjuvant pembrolizumab.

Patients with Claudin-6–positive advanced solid tumors, including platinum-resistant ovarian cancer, tended to respond to therapy with TORL-1-23

The agency approved the subcutaneous injection of atezolizumab and hyaluronidase-tqjs for all of the adult indications as the intravenous formulation of atezolizumab.

Companion diagnostics have been approved by the FDA for olaparib plus abiraterone in patients with metastatic castration-resistant prostate cancer.

Tumor sizes reduced from treatment with VP-315 in patients with basal cell carcinoma.

A supplemental biologics license application has been accepted by the FDA for nivolumab plus ipilimumab as first-line treatment for unresectable hepatocellular carcinoma.

First-line amivantamab plus lazertinib has been approved by the FDA for locally advanced or metastatic EGFR-mutated non–small cell lung cancer.

The KeyVibe-008 trial evaluating vibostolimab, pembrolizumab, and chemotherapy in extensive-stage small cell lung cancer has been discontinued.

Neoadjuvant durvalumab plus chemotherapy, followed by adjuvant durvalumab, received approval from the FDA for select patients with resectable non–small cell lung cancer.

Adding IMNN-001 to perioperative chemotherapy enhanced overall survival in patients with newly diagnosed, advanced ovarian cancer.

The biologics license application that was resubmitted for remestemcel-L has been accepted by the FDA for the potential treatment of children with steroid-refractory acute graft-vs-host-disease.

Fast track designation has been granted from the FDA to HP518 to treat androgen receptor–positive triple-negative breast cancer.

Crofelemer missed the diarrhea endpoint in a study assessing prophylaxis in adult patients with solid tumors receiving targeted therapy.

Accelerated approval has been granted by the FDA to afamitresgene autoleucel for certain patients with pretreated unresectable or metastatic synovial sarcoma.

A dostarlimab-gxly combination was approved for advanced or recurrent endometrial cancer.

The TIL cell therapy OBX-115 received fast track designation from the FDA for locally advanced or metastatic melanoma.

The antibody drug conjugate BNT324/DB-1311 received fast track designation for the potential treatment of unresectable advanced or metastatic castration-resistant prostate cancer with disease progression.