Kristi Rosa

A biologics license application seeking the approval of 131I-omburtamab in the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma has been resubmitted to the FDA.

The addition of relacorilant to nab-paclitaxel improved overall survival compared with nab-paclitaxel alone in patients with recurrent, platinum-resistant ovarian cancer.

The combination of eftilagimod alpha and pembrolizumab was found to produce an encouraging early overall survival rate of 73% at the 6-month landmark when used as second-line treatment in patients with PD-1/PD-L1–refractory, metastatic non–small cell lung cancer, according to data from part B of the phase 2 TACTI-002 trial.

Rucaparib significantly improved investigator-assessed progression-free survival over placebo when used as maintenance treatment in newly diagnosed patients with advanced ovarian cancer following successful first-line treatment with platinum-based chemotherapy, according to top-line findings from the monotherapy arm of the phase 3 ATHENA trial.

The addition of the anti-TIGIT immunotherapy tiragolumab to atezolizumab plus carboplatin/etoposide failed to significantly improve progression-free survival over atezolizumab/chemotherapy alone when used in the frontline treatment of patients with extensive-stage small cell lung cancer, missing the co-primary end point of the phase 3 SKYSCRAPER-02 trial.

The FDA has granted priority review to a new drug application seeking the approval of futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions.

The FDA has granted an orphan drug designation to Veyonda, a novel proprietary formulation of idronoxil, for use as a potential therapeutic option in patients with soft tissue sarcoma.

The European Medicines Agency has validated its type II variation application for nivolumab in combination with chemotherapy for use in the neoadjuvant treatment of patients with unresectable stage IB to IIIA non–small cell lung cancer.

A biologics license application has been submitted to the FDA for the use of mirvetuximab soravtansine monotherapy in patients with platinum-resistant ovarian cancer and high folate receptor–alpha expression who have received 1 to 3 prior systemic treatments.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use in combination with chemotherapy with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer who have a PD-L1 combined positive score of 1 or higher.

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.