Kristi Rosa

The rolling biologics license application submission to the FDA to support the approval of omidubicel for patients with blood cancers in need of allogenic hematopoietic stem cell transplant has been completed.

The FDA has granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

The FDA has approved nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, irrespective of PD-L1 status.

The European Commission has approved the combination of polatuzumab vedotin and rituximab and cyclophosphamide, doxorubicin, and prednisone for use in adult patients with previously untreated diffuse large B-cell lymphoma.

The FDA has approved ivosidenib (Tibsovo) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

The FDA has granted a fast track designation to seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor NRG1 gene fusions.

Nirogacestat was found to significantly improve progression-free survival over placebo when used in the treatment of adult patients with progressing desmoid tumors, meeting the primary end point of the phase 3 DeFi trial.

A biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin in patients with BCG-unresponsive, non–muscle invasive bladder cancer carcinoma in situ with or without Ta or T1 disease has been submitted to the FDA.

The FDA has approved azacitidine (Vidaza) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of selinexor in combination with bortezomib and low-dose dexamethasone for use in adult patients with multiple myeloma who have previously received 1 to 3 prior lines of treatment.

The addition of orteronel to androgen deprivation therapy vs bicalutamide improved progression-free survival and prostate-specific antigen response in patients with metastatic hormone-sensitive prostate cancer, but missed the primary end point of overall survival in the phase 2 SWOG-1216 trial.

The combination of the TROP2-directed antibody-drug conjugate datopotamab deruxtecan and durvalumab showcased early activity with acceptable safety when used as first-line treatment in patients with locally advanced or metastatic triple-negative breast cancer, according to data from the phase 1b/2 BEGONIA trial.

Stereotactic body radiation therapy in combination with nivolumab and ipilimumab demonstrated clinically meaningful antitumor activity with a favorable toxicity profile in difficult-to-treat patients with refractory metastatic pancreatic cancer, although the contribution of SBRT is still unclear.

Selinexor monotherapy prolonged progression-free survival, time to next treatment, and reduced pain in patients with advanced, refractory dedifferentiated liposarcoma.

The recombinant humanized anti–PD-1 monoclonal antibody toripalimab elicited an encouraging objective response rate with an acceptable toxicity profile in patients with metastatic urothelial cancer who were refractory to frontline chemotherapy.

The combination of nivolumab plus ipilimumab was not found to significantly improve overall survival over standard-of-care chemotherapy when used in the first-line treatment of patients with unresectable or metastatic urothelial carcinoma with a PD-L1 expression of 1% or higher.

The addition of isatuximab-irfc to carfilzomib and dexamethasone resulted in a significant improvement in progression-free survival vs carfilzomib plus dexamethasone alone in patients with relapsed or refractory multiple myeloma.

Results from a detailed safety analysis of the pivotal phase 3 HERO trial showed that relugolix, an oral gonadotropin-releasing hormone receptor antagonist, had an acceptable toxicity profile with favorable tolerability in patients with advanced prostate cancer.

The anti-TIGIT immunotherapy tiragolumab in combination with atezolizumab did not improve progression-free survival over atezolizumab alone in the first-line treatment of patients with PD-L1–high locally advanced or metastatic non–small cell lung cancer.

The addition of adjuvant abemaciclib to endocrine therapy resulted in a clinically meaningful reduction in the risk of developing invasive disease, particularly incurable distant metastatic disease, in patients with high-risk, hormone receptor–positive, HER2-negative, early breast cancer who comprised cohort 1 of the phase 3 monarchE trial.

A novel combination comprised of the investigational bispecific antibody CTX-009 and paclitaxel was found to produce responses in 4 subtypes of biliary tract cancer with favorable safety and tolerability, according to interim results from an ongoing phase 2 trial.

The FDA has approved fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received an anti–HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within 6 months of therapy completion.

The FDA has granted a fast track designation to the myeloid kinome inhibitor, HM43239, for use as a potential therapeutic option in patients with relapsed or refractory acute myeloid leukemia whose tumors harbor a FLT3 mutation.

The FDA has accepted a supplemental biologics license application and granted priority review to durvalumab in combination with standard gemcitabine and cisplatin for the treatment of patients with locally advanced or metastatic biliary tract cancer.

The European Commission has approved the use of cabozantinib for use as a single agent in adult patients with locally advanced or metastatic differentiated thyroid carcinoma who are refractory or not eligible to receive radioactive iodine and who have progressed during or following previous systemic treatment.

The FDA has accepted a supplemental new drug application and granted priority review to darolutamide plus docetaxel in patients with metastatic hormone-sensitive prostate cancer.

The FDA is seeking the approval of toripalimab plus gemcitabine and cisplatin in the frontline treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for use as a monotherapy in the second-line and later treatment of those with recurrent or metastatic disease.

The FDA has issued a complete response letter to the new drug application seeking the approval of surufatinib for the treatment of patients with pancreatic and extra-pancreatic neuroendocrine tumors.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval under conditional marketing authorization for mosunetuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 therapies.

The FDA has accepted for priority review a biologics license application seeking the approval of a single priming dose of tremelimumab added to regular interval durvalumab in the treatment of patients with unresectable hepatocellular carcinoma.