Chris Ryan

The FDA has granted fast track designation to narmafotinib for the treatment of advanced pancreatic cancer.

The CHMP has issued positive opinions for 2 pembrolizumab-based regimens for select patients with endometrial and cervical cancers.

The FDA has approved amivantamab plus chemotherapy for locally advanced or metastatic NSCLC harboring select EGFR mutations after an EGFR TKI.

Rintatolimod plus durvalumab led to stable disease at 6 months in 2 of 3 patients with late-stage pancreatic cancer treated at the first dose level.

The FDA has granted orphan drug designation to the novel oncolytic virotherapy CF33-hNIS for cholangiocarcinoma.

The FDA has granted regenerative medicine advanced therapy designation to P-BCMA-ALL01 for relapsed/refractory multiple myeloma.

China’s NMPA granted breakthrough therapy designation to belantamab mafodotin plus bortezomib and dexamethasone in relapsed/refractory myeloma.

The FDA has lifted the partial clinical hold previously placed on studies evaluating azenosertib in advanced solid tumors.

TORL-1-23 was safe and active in heavily pretreated, Claudin-6–positive advanced solid tumors, including platinum-resistant ovarian cancer.

Neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, improved overall survival in triple-negative breast cancer.

The FDA has approved subcutaneous atezolizumab for use in all indications as the intravenous formulation.

The FDA has granted orphan drug designation to tebapivat for the treatment of myelodysplastic syndromes.

THIO followed by cemiplimab generated a potential overall survival benefit in third-line advanced non–small cell lung cancer.

Treatment with aumolertinib led to an improvement in progression-free survival in unresectable, stage III, EGFR-mutated non–small cell lung cancer.

HS-20093 produced responses in extensive-stage small cell lung cancer after prior platinum-based chemotherapy with or without prior immunotherapy.

Treatment with valemetostat demonstrated activity and was tolerable in patients with relapsed/refractory peripheral T-cell lymphoma.

D-VRd improved rates of MRD negativity and sustained MRD negativity vs VRd in transplant-eligible, newly diagnosed multiple myeloma.

Pyrotinib paired with metronomic vinorelbine was safe and displayed efficacy in HER2-positive advanced breast cancer after prior trastuzumab.

The phase 3 IOB-013/KN-D18 trial of IO102-IO103 plus pembrolizumab in advanced melanoma will continue without modifications.

The FDA approved companion diagnostics for olaparib plus abiraterone in metastatic castration-resistant prostate cancer.

Azercabtagene zapreleucel produced complete responses in relapsed/refractory diffuse large B-cell lymphoma after prior autologous CAR T-cell therapy.

The European Commission has approved crovalimab for adult and pediatric patients with paroxysmal nocturnal hemoglobinuria.

The FDA has granted fast track designation to 64Cu-SAR-bisPSMA for PET imaging of PSMA-positive prostate cancer lesions.

OMX-0407 was safe and displayed activity in advanced solid tumors; dose-expansion cohorts will evaluate the agent in RCC and angiosarcoma.

The FDA has awarded rare pediatric disease designation and orphan drug designation to INV724 for the treatment of neuroblastoma.

The FDA has granted fast track designation to APG-157 for the neoadjuvant treatment of head and neck cancer.

Aadi Bioscience will end the PRECISION 1 trial evaluating nab-sirolimus in solid tumors harboring TSC1/2 alterations.

The FDA has accepted a supplemental biologics license application for nivolumab plus ipilimumab for first-line unresectable hepatocellular carcinoma.

The FDA has approved first-line amivantamab plus lazertinib for locally advanced or metastatic EGFR-mutated non–small cell lung cancer.

Jeffrey S. Weber, MD, PhD, inductee of the 2016 Giants of Cancer Care award in Melanoma, has died.