Kristi Rosa

The long-acting antibody combination of tixagevimab co-packaged with cilgavimab has been granted emergency use authorization in the United States for the pre-exposure prophylaxis of COVID-19.

The FDA has granted breakthrough therapy designation to CLN-081 for the treatment of patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations and who have received prior platinum-based chemotherapy.

The FDA has granted a rare pediatric disease designation to IMX-110 for the treatment of rhabdomyosarcoma.

The FDA has granted a fast track designation to a combination comprised of the immunogene therapy quaratusugene ozeplasmia and pembrolizumab for use in select patients with late-stage non–small cell lung cancer.

A new drug application seeking the approval of valemetostat tosylate for use in the treatment of patients with relapsed/refractory adult T-cell leukemia/lymphoma has been submitted to the Japanese Ministry of Health, Labour, and Welfare.

The European Medicines Agency has validated the Type II Variation application for fam-trastuzumab deruxtecan-nxki as a treatment for adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 1 or more anti–HER2-based regimens.

The Japanese Ministry of Health, Labour, and Welfare has approved the combination of pembrolizumab plus lenvatinib for use in patients with unresectable, advanced, or recurrent endometrial carcinoma that has progressed on chemotherapy.

A biologics license application seeking the approval of teclistamab for use in patients with relapsed or refractory multiple myeloma has been submitted to the FDA.

Frontline nivolumab plus ipilimumab showcased improved overall survival over chemotherapy and a trend toward improved intracranial progression-free survival and duration of response in patients with advanced non–small cell lung cancer.

A new drug application has been submitted to the FDA seeking the marketing approval of dovitinib as a potential option in the third-line treatment of patients with renal cell carcinoma.

The China National Medical Products Administration has granted a conditional marketing approval to selinexor for use in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have previously received treatment and whose disease is refractory to at least a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

A biologics license application has been submitted to the FDA seeking the approval of a proposed biosimilar for trastuzumab, a monoclonal antibody that is utilized in the treatment of patients with HER2-positive breast cancer and metastatic gastric cancers.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of single-agent pembrolizumab for use as an adjuvant treatment in adult patients with renal cell carcinoma who are at increased risk of recurrence after nephrectomy, or following nephrectomy and the resection of metastatic lesions.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of the approval of enfortumab vedotin as a monotherapy in the treatment of adult patients with locally advanced or metastatic urothelial cancer.

Preclinical evidence suggests that pairing KO-539 with targeted agents directed against BCL-2, BET, and CDK6 could result in superior efficacy against KMT2A-rearranged and NPM1-mutated acute myeloid leukemia.

The FDA has approved abatacept for the prophylaxis of acute graft-versus-host disease, in combination with certain immunosuppressants.

A single infusion of ciltacabtagene autoleucel produced an overall response rate of 95% in patients with multiple myeloma who had received a median of 2 prior lines of treatment and who were refractory to lenalidomide.

The utilization of oral azacitidine as maintenance treatment in patients with acute myeloid leukemia in first remission following intensive chemotherapy continued to showcase a survival benefit over placebo.

The addition of ublituximab and umbralisib to ibrutinib produced deep remissions with favorable tolerability in patients with chronic lymphocytic leukemia who previously received ibrutinib and still had detectable minimal residual disease.

Fixed-duration treatment with the bispecific antibody mosunetuzumab induced deep and durable responses with favorable tolerability in heavily pretreated patients with relapsed or refractory follicular lymphoma, meeting the primary end point of the ongoing phase 1/2b GO29781 trial.

The dual immunotherapy combination comprised of nivolumab and ipilimumab improved overall survival vs chemotherapy in patients with advanced non–small cell lung cancer, irrespective of KRAS, TP53, or STK11 mutational status, according to data from exploratory analyses of part 1 of the CheckMate-227 trial.

The addition of the bispecific antibody zanidatamab to single-agent chemotherapy was found to produce promising antitumor activity with acceptable tolerability in heavily pretreated patients with HER2-positive breast cancer.

The FDA has approved FoundationOne CDx for use as a companion diagnostic for 2 groups of current a future regulatory-approved treatments in melanoma, including single-agent BRAF inhibitors targeting BRAF V600E mutations and BRAF/MEK combination regimens targeting BRAF V600E or V600K mutations.

A new drug application seeking the approval of poziotinib as a potential therapeutic option for patients with previously treated locally advanced or metastatic non–small cell lung cancer with HER2 exon 20 insertion mutations has been submitted to the FDA.

Secura Bio, Inc. has decided to voluntarily withdraw the indication of duvelisib for use in patients with relapsed or refractory follicular lymphoma following at least 2 previous systemic therapies.

The FDA has approved pembrolizumab for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection.

The addition of darolutamide to docetaxel and androgen deprivation therapy resulted in a significant improvement in overall survival compared with docetaxel/ADT alone in patients with metastatic hormone-sensitive prostate cancer, meeting the primary end point of the phase 3 ARASENS trial.

The FDA has granted priority review to the supplemental biologics license application for luspatercept-aamt for the treatment of anemia in adults with non–transfusion dependent β-thalassemia.

The FDA has approved rituximab plus chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.

Secura Bio decided to withdraw the approval of the new drug application for panobinostat for use in combination with bortezomib and dexamethasone to treat select patients with multiple myeloma.