Kristi Rosa

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended to expand the current indication for avapritinib to include single-agent use in patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, or mast cell leukemia.

The FDA has approved an update to the prescribing information for axicabtagene ciloleucel to include use of prophylactic corticosteroids across all approved indications.

Regeneron Pharmaceuticals, Inc. and Sanofi announced the voluntarily withdrawal of the supplemental biologics license application for cemiplimab-rwlc as a second-line treatment for patients with advanced cervical cancer whose disease progressed on or after chemotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B following 2 or more lines of systemic therapy.

The European Commission has granted a marketing authorization for lorlatinib for use as a single agent in the treatment of adult patients with ALK-positive advanced non–small cell lung cancer who did not receive a prior ALK inhibitor.

The FDA has placed a partial clinical hold on clinical trials evaluating the combination of magrolimab and azacitidine after an apparent imbalance in investigator-reported, suspected unexpected serious adverse reactions observed between study arms.

The global biopharmaceutical company Incyte has decided to withdraw the new drug application for parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma.

The FDA has approved tebentafusp-tebn for the treatment of HLA-A*02:01–positive adult patients with unresectable or metastatic uveal melanoma.

The FDA has granted a fast track designation to CX-5461 (Pidnarulex) as a potential therapeutic option for patients with breast and ovarian cancers that harbor BRCA1/2, PALB2, or other homologous recombination deficiency mutations.

The PD-L1 antibody cosibelimab, when given at a fixed dose of 800 mg every 2 weeks, elicited a promising objective response rate with acceptable safety and tolerability in patients with metastatic cutaneous squamous cell carcinoma, meeting the primary end point of a phase 1 registration-enabling trial.

Momelotinib provided a statistically significant benefit in terms of splenic symptoms, anemia, and splenic size in patients with myelofibrosis.

Tislelizumab in combination with chemotherapy significantly improved overall survival vs chemotherapy alone when used in the frontline treatment of patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors expressed PD-L1, meeting the primary end point of the phase 3 RATIONALE 305 trial.

The FDA has granted an orphan drug designation to eltanexor, an investigational novel SINE compound, as a potential therapeutic option for patients with myelodysplastic syndromes.

The FDA has lifted a partial clinical hold on the phase 1b KOMET-001 trial, which is evaluating KO-539 as a therapeutic option in patients with relapsed or refractory acute myeloid leukemia.

The safety and tolerability of TST001 is under investigation as a potential treatment option for patients with gastric/gastroesophageal junction cancer and other locally advanced or metastatic solid tumors as part of a phase 1 trial.

The China National Medical Products Administration has accepted a supplemental new drug application for zanubrutinib as a treatment for adult patients with Waldenström macroglobulinemia.

The FDA has granted an orphan drug designation to silmitasertib for use as a potential therapeutic option in patients with biliary tract cancer.

Neoadjuvant nivolumab plus ipilimumab followed by adjuvant nivolumab elicited a pathologic complete response rate of 59% in patients with resectable microsatellite instable or mismatch repair deficient oeso-gastric junction adenocarcinoma.

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.