Kristi Rosa

The FDA’s Office of Orphan Products Development has granted an orphan drug designation to the multitumor-associated antigen-specific T-cell therapy, MT-601, for the treatment of patients with pancreatic cancer.

The Japanese Ministry of Health, Labour, and Welfare has approved idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 3 therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have progressed on their last therapy or relapsed following their last therapy.

The addition of the PD-L1 inhibitor sugemalimab to chemotherapy significantly improved overall survival compared with chemotherapy alone in the frontline treatment of patients with stage IV non–small cell lung cancer.

The FDA has granted a fast track designation to gedatolisib for use as a potential therapeutic option in patients with hormone receptor–positive, HER2-negative metastatic breast cancer who experienced disease progression on CDK4/6 therapy.

The FDA has accepted for review a supplemental biologics license application for cemiplimab-rwlc in combination with chemotherapy in the frontline treatment of patients with advanced non–small cell lung cancer.

Gilead Sciences, Inc. has decided to voluntarily withdraw the indications of idelalisib in patients with relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma who had received at least 2 prior systemic therapies.

The Scottish Medicines Consortium has accepted fam-trastuzumab deruxtecan-nxki as a treatment option for adult patients with HER2-positive unresectable or metastatic breast cancer who have previously received 2 or more anti–HER2-based therapies.

The FDA has granted priority review to the supplemental biologics license application of fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti–HER2-based regimen.1

The addition of ADXS-503 to the treatment of patients with metastatic non–small cell lung cancer who were progressing on pembrolizumab (Keytruda) resulted in encouraging responses and durable disease control, according to findings from the phase 1/2 trial.

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.