Kristi Rosa

The Ministry of Health, Labour, and Welfare has accepted a supplemental new drug application for lisocabtagene maraleucel for the second-line treatment of patients with relapsed or refractory large B-cell lymphoma.

The FDA has extended the review period for the supplemental biologics license application for luspatercept-aamt as a treatment for anemia in adults with non–transfusion-dependent β-thalassemia.

The FDA has discouraged the pursuit of a marketing authorization of the PI3K inhibitor zandelisib in patients with follicular lymphoma or marginal zone lymphoma, citing the need for randomized trial data.

The European Commission has expanded the current indication for avapritinib to include use as a single agent in adult patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, or mast cell leukemia, following at least 1 systemic treatment.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of the approval of polatuzumab vedotin for use in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone in patients with previously untreated diffuse large B-cell lymphoma.

The European Medicines Agency’s Committee for Medical Products for Human Use has recommended the approval of ruxolitinib for the treatment of patients with acute or chronic graft-vs-host disease who are aged 12 years or older and who have inadequate response to corticosteroids or other systemic therapies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of tisagenlecleucel for use in adult patients with relapsed/refractory follicular lymphoma following 2 lines of systemic treatment.

Durvalumab given concurrently with chemoradiation was not found to significantly improve progression-free survival vs chemoradiation alone in patients with locally advanced cervical cancer, missing the primary end point of the phase 3 CALLA trial.

The FDA has issued a complete response letter to the biologics license application seeking the approval of sintilimab injection in combination with pemetrexed and platinum chemotherapy in the frontline treatment of patients with nonsquamous non–small cell lung cancer.

An independent data monitoring committee has recommended that the phase 3 INNOVATE-3 trial exploring the safety and efficacy of tumor treating fields in combination with paclitaxel in patients with platinum-resistant ovarian cancer proceed to the final analysis.

The FDA has approved lutetium Lu 177 vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have previously received other anticancer therapies.

Temozolomide priming followed by the combination of low-dose ipilimumab and nivolumab may produce durable clinical benefit in microsatellite stable and MGMT-silenced metastatic colorectal cancer.

The combination of abemaciclib and letrozole produced encouraging responses with an acceptable toxicity profile in patients with estrogen receptor–positive, recurrent or metastatic endometrial cancer with endometrioid histology, according to data from a phase 2 trial.

The FDA has approved pembrolizumab for use as a single agent in the treatment of patients with advanced endometrial carcinoma that is microsatellite instability–high or mismatch repair deficient, and who experienced disease progression following previous systemic therapy in any setting and are not candidates for curative surgery or radiation.

Mirvetuximab soravtansine was found to produce clinically meaningful antitumor activity with acceptable safety and tolerability in patients with platinum-resistant ovarian cancer and high folate receptor–alpha (FRα) expression.

The FDA has approved the fixed-dose combination of relatlimab plus nivolumab for the treatment of adult and pediatric patients who are 12 years of age or older and who have unresectable or metastatic melanoma.

Pembrolizumab was found to significantly improve disease-free survival vs placebo when used in the adjuvant treatment of patients with stage IB to IIIA non–small cell lung cancer following surgical resection, meeting 1 of the dual primary end points of the phase 3 KEYNOTE-091 trial.

Selinexor reduced the risk of disease progression or death by 30% in an audited intent-to-treat population of patients with advanced or recurrent endometrial cancer who received frontline chemotherapy, and by 62% in a subset of patients with p53 wild-type disease, according to data from the phase 3 SIENDO trial.

The FDA has granted an orphan drug designation to the investigative allogeneic unmodified gamma delta T-cell product, TCB-002, for use as a potential therapeutic option in patients with relapsed/refractory acute myeloid leukemia.

The FDA has granted a fast track designation to the novel immunostimulant 7HP349 for use in combination with a CTLA-4 inhibitor in patients with unresectable or metastatic malignant melanoma in whom a PD-L1 inhibitor has failed.

The FDA has approved the FoundationOne CDx for use as a companion diagnostic to determine which patients with non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 substitutions may derive benefit from EGFR TKIs that have been greenlit by the agency for this indication.

At a median follow-up of 3.5 years, adjuvant olaparib significantly improved overall survival vs placebo in patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer who received prior chemotherapy before or after surgery.

The Ministry of Health, Labour, and Welfare has approved Guardant360 CDx to perform comprehensive genomic profiling in patients with advanced solid cancers.

The fixed-dose combination of relatlimab and nivolumab continued to demonstrate a consistent progression-free survival benefit, showcased a clinically meaningful improvement in overall survival, and elicited a higher objective response rate than nivolumab alone in previously untreated patients with metastatic or unresectable melanoma.

Allarity Therapeutics, Inc. has filed a formal request with the FDA to hold a Type C meeting where they can discuss possible clinical paths to support the approval of dovitinib in renal cell carcinoma, as well as its DRP-Dovitinib companion diagnostic.

The phase 3 KEYLYNK-001 trial evaluating the combination of pembrolizumab and olaparib in patients with metastatic castration-resistant prostate cancer who progressed following chemotherapy and either abiraterone acetate or enzalutamide will be discontinued for futility.

The combination of cabozantinib and atezolizumab was not found to result in an improvement nor a detriment in overall survival vs sorafenib when used in previously untreated patients with advanced hepatocellular carcinoma, according to data from the phase 3 COSMIC-312 trial.

Amcenestrant did not improve progression-free survival per independent central review vs physician’s choice of endocrine treatment in select patients with locally advanced or metastatic, estrogen receptor–positive, HER2-negative breast cancer, missing the primary end point of the phase 2 AMEERA-3 trial.

The addition of bempegaldesleukin to nivolumab did not significantly improve progression-free survival, objective response rate, or overall survival vs nivolumab alone in the frontline treatment of patients with unresectable or metastatic melanoma, missing the primary end points of the phase 3 PIVOT IO-001 trial.

The FDA has approved the BRACAnalysis CDx assay for use as a companion diagnostic to select patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer who may derive clinical benefit from treatment with olaparib.