Chris Ryan

The FDA has granted accelerated approval to zanidatamab for pretreated, advanced HER2-positive biliary tract cancer.

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

Nogapendekin alfa inbakicept plus BCG continued to generate complete responses in BCG-unresponsive non–muscle-invasive bladder cancer.

Second-line BTK inhibitors were associated with improved PFS2 and OS2 in late-relapsed mantle cell lymphoma.

The CHMP has recommended repotrectinib for ROS1-positive non–small cell lung cancer and NTRK-positive solid tumors.

The CHMP has recommended the approval of pembrolizumab plus chemotherapy for first-line unresectable non-epithelioid malignant pleural mesothelioma.

The CHMP has recommended the EU approval of isatuximab plus VRd for newly diagnosed, transplant-ineligible multiple myeloma.

GRANITE-based maintenance therapy improved PFS in first-line MSS colorectal cancer.

The FDA has approved nilotinib tablets without mealtime restrictions for select patients with chronic myeloid leukemia.

NXP800 generated antitumor activity as monotherapy in platinum-resistant ovarian cancer harboring ARID1a mutations.

Eftilagimod alpha plus pembrolizumb and chemotherapy generated favorable survival data in nonsquamous NSCLC.

177Lu-PSMA-I&T improved radiographic progression-free survival vs hormonal therapy in PSMA-positive metastatic castration-resistant prostate cancer.

AstraZeneca has filed a new BLA for Dato-DXd in pretreated, EGFR-mutated advanced non–small cell lung cancer.

Pimicotinib improved responses compared with placebo in tenosynovial giant cell tumor.

Selumetinib led to a statistically significant and clinically meaningful improvement in ORR compared with placebo in adult patients with neurofibromatosis.

RP1 plus nivolumab generated responses in advanced melanoma that progressed on or after prior anti–PD-1 therapy.

The FDA has approved obecabtagene autoleucel for relapsed/ refractory B-cell precursor acute lymphoblastic leukemia.

A new drug application has been submitted to the FDA for sunvozertinib in pretreated EGFR exon 20–positive advanced non–small cell lung cancer.

Applications have been submitted to the FDA and EMA seeking approval for daratumumab in high-risk smoldering multiple myeloma.

The Immune Profile Score algorithmic test is now available for clinical use as a prognostic tool for immune checkpoint inhibitors in solid tumors.

Siglec-15 was expressed in tumor cells and tumor-associated macrophages in tissue samples from non–small cell lung cancer and other solid tumors.

An indirect comparison did not show significant differences in survival for acalabrutinib vs ibrutinib in relapsed/refractory mantle cell lymphoma.

The FDA has extended the PDUFA date of the BLA for zenocutuzumab in NRG1-positive non–small cell lung cancer and pancreatic cancer.

Regorafenib improved overall survival vs placebo in refractory advanced gastric or gastroesophageal junction cancer.

BXQ-350 was well tolerated and generated clinical activity in patients with advanced solid tumors.

A rolling NDA seeking the approval of avutometinib plus defactinib in recurrent KRAS-mutant low-grade serous ovarian cancer has been submitted to the FDA.

The FDA has granted regenerative medicine advanced therapy to ALLO-316 in CD70-positive advanced or metastatic renal cell carcinoma.

The FDA has extended the PDUFA date for sotorasib plus panitumumab application in KRAS G12C+ metastatic colorectal cancer.

The FDA has received an NDA seeking the approval of a 3-month formulation of leuprolide mesylate for advanced prostate cancer.

The FDA has granted accelerated approval to asciminib for newly diagnosed, Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.