Kristi Rosa

The FDA has granted a regenerative medicine advanced therapy designation and a fast track designation to C-CAR039 for use as a potential therapeutic option in patients with relapsed or refractory diffuse large B-cell lymphoma.

The FDA has granted a breakthrough device designation to BNT200, a prescription-only digital therapeutic to leverage in the treatment of anxiety and depressive symptoms created by psychological stressors experienced by adults with acute myeloid leukemia who are hospitalized and undergoing high-intensity induction chemotherapy.

The diffusing alpha-emitter radiation therapy, Alpha DaRT, was found to elicit complete responses per RECIST v1.1 criteria in 10 patients with malignant skin and soft tissue cancers who are enrolled to an ongoing single-institution pilot feasibility trial.

The Data Safety Monitoring Board has determined that it is safe and appropriate to continue recruitment to the expansion arm of the phase 1/2 GLORIA trial, which is examining a novel combination comprised of NOX-A12, radiotherapy, and bevacizumab in glioblastoma and incomplete tumor resection.

The novel antimetabolite aspacytarabine was found to produce a complete remission rate of 37% in adult patients with newly diagnosed acute myeloid leukemia who are unfit for intensive therapy.

The European Commission has granted conditional marketing authorization to sotorasib for the treatment of adult patients with KRAS G12C mutant advanced non–small cell lung cancer.

The FDA has granted a fast track designation to enobosarm as a potential therapeutic option for patients with androgen receptor–positive, estrogen receptor–positive, HER2-negative, metastatic breast cancer who progressed on a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor, and who have AR staining of 40% or more in cancer tissue.

Adjuvant treatment with pembrolizumab led to a statistically significant and clinically meaningful improvement in disease-free survival vs placebo in patients with stage IB to IIIA non–small cell lung cancer following resection, regardless of PD-L1 expression, meeting 1 of the dual primary end points of the phase 3 KEYNOTE-091 trial.

No dose-limiting toxicities have been reported in the first cohort of patients with relapsed clear cell sarcoma who received the combination of devimistat and hydroxychloroquine in the dose-escalation portion of the ongoing phase 1/2 APOLLO 613 trial.

CA-4948 monotherapy was found to have preliminary activity with acceptable safety and tolerability in patients with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndromes, according to updated data from an ongoing phase 1/2 trial.

The FolRα-targeted antibody-drug conjugate STRO-002 was found to elicit encouraging responses in heavily pretreated patients with advanced ovarian cancer.

The combination of pembrolizumab and pepinemab showcased encouraging safety and tolerability when given as first-line treatment in patients with advanced, recurrent, or metastatic head and neck squamous cell carcinoma.

The FDA granted a breakthrough therapy designation to telisotuzumab vedotin for use in patients with advanced or metastatic EGFR wild-type, nonsquamous non–small cell lung cancer who have high levels of c-Met overexpression and whose disease has progressed on, or after, platinum-based chemotherapy.

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.