Kristi Rosa

The FDA has extended the review period for the new drug application seeking the approval of momelotinib as a potential therapeutic option in patients with myelofibrosis.

The FDA has approved FoundationOne CDx for use as a companion diagnostic to determine patients with BRAF V600E–mutated metastatic colorectal cancer who may be candidates to receive encorafenib in combination with cetuximab.

Although the event rate did reach the expected level and longer follow-up is needed to adequately assess long-term toxicities, data from the phase 3 IELSG37 trial support the omission of radiotherapy in patients with primary mediastinal large B-cell lymphoma who achieve a complete metabolic response following chemoimmunotherapy.

The combination of daratumumab plus bortezomib, cyclophosphamide, and dexamethasone, elicited a complete response (CR) rate of 40% and a CR or better rate of 43% in patients with multiple myeloma presenting with extramedullary disease.

The FDA has removed a partial clinical hold that had been placed on a phase 1 trial investigating the safety and efficacy of MT-0169 as a potential therapeutic option in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma.

The FDA has accepted for review a supplemental biologics license application seeking the approval of pembrolizumab plus standard chemotherapy comprised of gemcitabine and cisplatin for use in patients with locally advanced unresectable or metastatic biliary tract cancer.

The addition of durvalumab to standard neoadjuvant chemotherapy significantly improved pathologic complete response over neoadjuvant chemotherapy alone in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers.

The FDA has extended the Prescription Drug User Fee Act decision date by 3 months to allow more time to complete their review of the new drug application seeking the approval of nirogacestat in the treatment of adult patients with desmoid tumors.

A supplemental biologics license application seeking the approval of ciltacabtagene autoleucel for use in adult patients with relapsed and lenalidomide-refractory multiple myeloma who have previously received at least 1 line of therapy, including a proteasome inhibitor and an immunomodulatory agent, has been submitted to the FDA.

Sotorasib provided consistent benefit over docetaxel in the majority of key prespecified molecularly defined subsets of patients with pretreated KRAS G12C–mutated non–small cell lung cancer enrolled to the phase 3 CodeBreaK 200 trial.

The FDA has accepted and granted priority review to a supplemental biologics license application seeking the approval of dostarlimab plus chemotherapy for use in adult patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.

The combination of pembrolizumab plus axitinib continued to improve overall survival, progression-free survival, and overall response rate over sunitinib monotherapy in patients with treatment-naïve clear cell renal cell carcinoma.

The SEZ6-targeted antibody-drug conjugate ABBV-011, when administered at 1 mg/kg every 3 weeks, was found to be well tolerated and to demonstrate early efficacy in patients with relapsed or refractory small cell lung cancer.

Neoadjuvant treatment with fluorouracil, leucovorin, and oxaliplatin proved to be as effective as pelvic chemoradiation with fewer adverse effects in patients with locally advanced rectal cancer who were eligible for sphincter-sparing surgery.

When administered at doses of 90 μg/kg or higher, the novel DLL3-targeting T-cell engager, BI 764532, was found to have an acceptable toxicity profile and to elicit encouraging responses in patients with DLL3-positive small cell lung cancer and neuroendocrine carcinoma.

Brexucabtagene autoleucel elicited high rates of complete remission with minimal residual disease negativity in real-world patients with relapsed or refractory B-cell acute lymphoblastic leukemia who received the CAR T-cell product as post-approval, standard-of-care treatment, according to data from a retrospective study.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of piflufolastat 18F, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent, for use in prostate cancer detection.

The first patient has been dosed with the autologous CAR T-cell therapy A2B530 in the multicenter, first-in-human, phase 1/2 EVEREST-1 study.

The China National Medical Products Adminstration’s Center for Drug Evaluation has recommended that olverembatinib receive breakthrough therapy designation for the treatment of patients with gastrointestinal stromal tumor that is succinate dehydrogenase deficient.

The FDA has approved olaparib (Lynparza) plus abiraterone acetate (Zytiga) and prednisone or prednisolone for the treatment of patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.

The FDA has approved flotufolastat F 18 injection (Posluma) for positron emission tomography of prostate-specific membrane antigen–positive lesions in men with prostate cancer with suspected metastasis who are eligible for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level.

A Type II variation application seeking the approval of ciltacabtagene autoleucel in adult patients with relapsed and lenalidomide-refractory multiple myeloma has been submitted to the European Medicines Agency.

Japan’s Ministry of Health, Labour, and Welfare has approved quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation and as maintenance monotherapy in patients with newly diagnosed acute myeloid leukemia whose tumors harbor FLT3-ITD mutations.

The FDA has granted priority review to the new drug application seeking the approval of fruquintinib for use in the treatment of adult patients with previously treated metastatic colorectal cancer.

Minimally invasive distal pancreatectomy was found to be a safe and effective alternative to that of open distal pancreatectomy in patients with resectable pancreatic cancer, confirmed by a noninferior radical resection rate, lymph node yield, and comparable survival data.

The National Medical Products Administration has accepted the supplemental new drug application seeking the approval of toripalimab in combination with nab-paclitaxel in patients with untreated metastatic or recurrent triple-negative breast cancer and a PD-L1 combined positive score of at least 1.

The FDA has granted priority review to a new drug application seeking the approval of the optical imaging agent Lumisight for use in patients with breast cancer, according to an announcement from Lumicell, Inc.

The FDA has approved avapritinib (Ayvakit) for the treatment of adults with indolent systemic mastocytosis.

The combination of GEN-002 and avelumab elicited responses in patients with advanced gastric or gastroesophageal junction adenocarcinoma, according to findings from an interim analysis of an ongoing phase 2 trial.

The FDA has approved the first T-cell–engaging bispecific antibody, epcoritamab-bysp (Epkinly), for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after 2 or more lines of systemic therapies.