Kristi Rosa

The combination of galinpepimut-S and nivolumab provided positive survival outcomes with an acceptable safety profile in patients with malignant pleural mesothelioma who were refractory to or relapsed after at least 1 line of standard treatment.

Epcoritamab elicited a confirmed overall response rate of 82% by independent review committee assessment in patients with relapsed or refractory follicular lymphoma who received 2 or more prior systemic treatments, which exceeded the prespecified threshold for efficacy in the phase 1/2 EPCORE NHL-1 trial.

Fixed-duration treatment with single-agent mosunetuzumab resulted in a high complete response rate by end of treatment in patients with relapsed or refractory follicular lymphoma, according to updated data from the phase 2 GO29781 trial.

The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion regarding sacituzumab govitecan-hziy monotherapy in select patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer.

The BrECADD combination had noninferior efficacy and superior tolerability compared with escalated BEACOPP in patients with advanced classical Hodgkin lymphoma, according to data from the phase 3 HD21 trial.

The FDA has granted regular approval to blinatumomab (Blincyto) for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease of at least 0.1%

A new drug application seeking the approval of imetelstat for use as a therapeutic option for transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndrome who have not responded to, lost response to, or were not candidates for erythropoiesis-stimulating agents has been submitted to the FDA.

The FDA has approved talazoparib (Talzenna) plus enzalutamide (Xtandi) for use in patients with homologous recombination repair gene–mutated metastatic castration-resistant prostate cancer.

A single administration of lisocabtagene maraleucel provided deep and durable remissions when used as third-line treatment in patients with relapsed or refractory follicular lymphoma, including those with high-risk features.

The addition of pembrolizumab to trastuzumab and chemotherapy improved progression-free survival over trastuzumab and chemotherapy alone when used as a frontline regimen in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

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.