Chris Ryan

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.

The FDA has lifted a partial clinical hold on the phase 1 trial evaluating YL202 in advanced breast cancer and EGFR-mutated non–small cell lung cancer.

The EMA has validated a type II variation application for trastuzumab deruxtecan for select patients with HER2-low or -ultralow metastatic breast cancer.

The FDA has approved neoadjuvant durvalumab plus chemotherapy, followed by adjuvant durvalumab, for select resectable non–small cell lung cancer.

The FDA granted priority review to durvalumab in limited-stage small cell lung cancer after platinum-based concurrent chemoradiotherapy.

Treatment with VP-315 led to reductions in tumor size in patients with basal cell carcinoma.

Enrollment will discontinue for the SELECT-AML-1 trial of tamibarotene/venetoclax/azacitidine in newly diagnosed, RARA-positive acute myeloid leukemia.

CIRT plus durvalumab and tremelimumab was safe in patients with advanced hepatocellular carcinoma with macrovascular invasion.

Isatuximab plus VRd induction improved progression-free survival in transplant-eligible, newly diagnosed multiple myeloma.

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

The FDA has approved denileukin diftitox-cxdl for relapsed/refractory cutaneous T-cell lymphoma after at least 1 prior systemic therapy.

The FDA has approved vorasidenib for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.

The FDA cleared the SeCore CDx HLA A Sequencing System as a companion diagnostic for afamitresgene autoleucel in advanced synovial sarcoma.

EO-3021 was safe and led to responses in advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2.

Pirtobrutinib generated responses in BTK inhibitor–naive relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.

The European Medicines Agency has granted orphan drug designation to SLS009 for relapsed/refractory peripheral T-cell lymphoma

The FDA has accepted a supplemental new drug application for cabozantinib in advanced pancreatic and extra-pancreatic neuroendocrine tumors.

The FDA has granted accelerated approval to afamitresgene autoleucel for select patients with pretreated unresectable or metastatic synovial sarcoma.

The FDA has approved dostarlimab plus carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer.

The EMA has granted orphan medicinal product designation to rivoceranib plus camrelizumab in first-line unresectable hepatocellular carcinoma.

The FDA granted fast track designation to IMM-1-104 for first-line pancreatic ductal adenocarcinoma.

The European Medicines Agency has approved Avzivi, a biosimilar referencing bevacizumab.