Chris Ryan

A biologics license application (BLA) has been submitted to the FDA for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma, according to an announcement from Janssen.

The combination of vusolimogene oderparepvec and nivolumab generated promising responses in patients with cutaneous melanoma who failed previous anti–PD-1 therapy, according to initial data from the phase 2 IGNYTE trial.

The development of zandelisib for the treatment of B-cell malignancies has been discontinued outside of Japan.

The FDA has granted a breakthrough therapy designation to revumenib for the treatment of adult and pediatric patients with relapsed/refractory acute leukemia harboring a KMT2A rearrangement.

Enrollment has been paused for a phase 1 trial investigating the peptide-drug conjugate TH1902 for the treatment of patients with sortilin-expressing cancers.

The combination of sintilimab and anlotinib elicited improved responses and progression-free survival compared with chemotherapy in previously untreated patients with metastatic non–small cell lung cancer.

The FDA has issued a complete response letter to the biologics license application seeking the approval of 131I-omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.

Dostarlimab plus standard-of-care chemotherapy, followed by dostarlimab alone, produced a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with primary advanced or recurrent endometrial cancer.

The FDA has granted an orphan drug designation to AUM302 for the treatment of patients with neuroblastoma.

The FDA has approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test.

The European marketing authorization application of infigratinib for the treatment of advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements has been withdrawn by Helsinn Birex Pharmaceuticals.

The FDA has accepted a biologics license application seeking the approval of a reformulation of denileukin diftitox for use as a potential therapeutic option in patients with persistent or recurrent cutaneous T-cell lymphoma.

The FDA has granted a fast track designation to batiraxcept for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma who have progressed after 1 or 2 prior lines of systemic therapy that include both immuno-oncology–based and VEGF TKI–based therapies, either in combination or sequentially.

The combination of nivolumab and ipilimumab, irrespective of the addition of stereotactic body radiation therapy, generated an overall response rate of 100% in patients with Merkel cell carcinoma who were naïve to immune checkpoint inhibitors.

Roche is voluntarily withdrawing the United States indication for atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

The United Kingdom’s Medicines and Healthcare products Regulatory Agency has approved darolutamide tablets in combination with androgen deprivation therapy and docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer.

Japan’s Ministry of Health, Labor, and Welfare has approved trastuzumab deruxtecan for the treatment of adult patients with HER2-positive unresectable or recurrent breast cancer after prior chemotherapy, which includes trastuzumab and a taxane.

The FDA has issued a complete response letter to the new drug application seeking the approval of poziotinib for the treatment of patients with previously treated locally advanced or metastatic non–small cell lung cancer with HER2 exon 20 insertion mutations.

The FDA has extended the Prescription Drug User Fee Act goal date to May 1, 2023, for the biologics license application seeking the approval of omidubicel for patients with blood cancers in need of allogenic hematopoietic stem cell transplant.

GlaxoSmithKline plc has initiated the process to withdraw the United States marketing authorization for belantamab mafodotin-blmf for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 4 prior therapies.

The European Commission has approved cemiplimab-rwlc monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer who have progressed on or after platinum-based chemotherapy.

The combination of pembrolizumab and physician’s choice of chemotherapy produced a statistically significant overall survival benefit vs chemotherapy plus placebo in patients with HER2-negative, locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

The oral PI3Kδ inhibitor zandelisib produced an overall response rate in Japanese patients with relapsed/refractory indolent B-cell non-Hodgkin lymphoma without small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and Waldenström macroglobulinemia.

The FDA has accepted and granted priority review to a biologics license application seeking the apporoval of epcoritamab in patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.

After receiving FDA feedback regarding supplemental assay validation information and comparability data for lifileucel in advanced melanoma, Iovance Biotherapeutics will address these comments and plans to complete its rolling biologics license application submission during the first quarter of 2023.

Camsirubicin in combination with pegfilgrastim produced encouraging clinical activity and safety in patients with advanced soft tissue sarcoma.

The FDA has granted an orphan drug designation to vebreltinib for the treatment of patients with non–small cell lung cancer harboring MET genomic tumor aberrations.

The combination of nivolumab and ipilimumab have shown overall survival benefit in patients with metastatic melanoma, according to long-term follow-up data, and other studies’ results highlight the efficacy and toxicity benefits of different sequences of the combination.

The addition of CBM588 to the combination of nivolumab and ipilimumab produced superior response rates and a progression-free survival benefit vs nivolumab plus ipilimumab alone in previously untreated patients with metastatic renal cell carcinoma.

Belantamab mafodotin-blmf did not generate a progression-free survival benefit vs the combination of pomalidomide plus low-dose dexamethasone, failing to meet the primary end point of the phase 3 DREAMM-3 trial.