Chris Ryan

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.

Durvalumab plus chemotherapy, followed by durvalumab maintenance with or without olaparib, improved responses in advanced endometrial cancer.

Vibostolimab plus pembrolizumab was not superior to pembrolizumab monotherapy in pretreated PD-L1–positive advanced cervical cancer.

XB2001 plus chemotherapy improved safety and was tied to a trend toward improved overall survival in pretreated advanced pancreatic cancer.

Tafasitamab plus lenalidomide has been granted priority review in China for transplant-ineligible, relapsed/refractory diffuse large B-cell lymphoma.

The FDA placed partial clinical holds on trials evaluating azenosertib in advanced solid tumors, including ovarian cancer and uterine serous carcinoma.

The FDA placed a partial clinical hold on a phase 1 trial evaluating YL202 in select patients with advanced non–small cell lung cancer or breast cancer.

The FDA has approved pembrolizumab plus carboplatin and paclitaxel, followed by pembrolizumab alone, for primary advanced or recurrent endometrial carcinoma.

A BLA is seeking the approval of subcutaneous amivantamab for all currently approved indications of the IV formulation in EGFR+ NSCLC.

Zanubrutinib was associated with improved cost savings and quality-adjusted life year benefits vs acalabrutinib in B-cell malignancies.

The FDA had approved durvalumab plus, followed by single-agent durvalumab, for dMMR primary advanced or recurrent endometrial cancer.

Zanubrutinib/venetoclax elicited a 100% overall response rate in untreated chronic lymphocytic leukemia harboring 17p deletions or TP53 mutations.

The FDA granted full approval to selpercatinib for select patients with advanced or metastatic RET fusion–positive thyroid cancer.

Decreases in variant allele frequency in ctDNA were linked to improved CBR with imlunestrant in estrogen receptor–positive, HER2-negative breast cancer

The FDA has granted priority review to the supplemental NDA seeking the approval of osimertinib in EGFR-mutated stage III non–small cell lung cancer.

The European Commission granted orphan drug designation to UCART22 for acute lymphoblastic leukemia.

Lunresertib plus camonsertib received FDA fast track designation for select patients with platinum-resistant ovarian cancer.

A clinically meaningful but not statistically significant improvement in OS was observed with uproleselan plus chemotherapy vs chemotherapy alone in primary refractory AML.

Daratumumab plus VRd increased rates of MRD negativity in newly diagnosed, transplant-eligible multiple myeloma.

The xM and xM NeXT Personal® Dx MRD assays are now available for detecting residual disease and early cancer recurrence in patients with cancer.

Trastuzumab deruxtecan improved PFS vs chemotherapy in pretreated, HR-positive, HER2-low or -ultralow metastatic breast cancer.

Osimertinib after definitive chemoradiotherapy improved PFS vs placebo in locally advanced, EGFR-mutated non–small cell lung cancer.