Kristi Rosa

The FDA has granted a fast track designation to PDS0101 for use in combination with pembrolizumab in patients with recurrent or metastatic HPV16-positive head and neck cancer.

The PD-L1 antibody cosibelimab was found to elicit an encouraging objective response rate in patients with locally advanced cutaneous squamous cell carcinoma who were not eligible to undergo curative surgery or radiation.

The addition of venetoclax to ibrutinib resulted in a high rate of minimal residual disease negativity in the blood and marrow of patients with previously untreated chronic lymphocytic leukemia.

Teclistamab was found to have improved effectiveness in terms of progression-free survival, time to next treatment, and overall survival vs real-world physician’s choice of therapy in patients with triple-class exposed relapsed/refractory multiple myeloma.

The combination of galinpepimut-S and nivolumab was found to extend survival in patients with malignant pleural mesothelioma who were either refractory to, or who had relapsed after, at least 1 line of standard therapy.

The European Commission has approved atezolizumab for use as an adjuvant treatment following complete resection and platinum-based chemotherapy in adult patients with non–small cell lung cancer and a high risk of recurrence whose tumors do not have EGFR mutations or ALK alterations but have a PD-L1 expression of 50% or higher.

The FDA has accepted for review a new supplemental biologics license application seeking approval of pembrolizumab in the adjuvant treatment of patients with stage IB to IIIA non–small cell lung cancer after complete surgical resection.

Bezuclastinib showcased early signs of clinical activity in that it resulted in a meaningful reduction in serum tryptase levels, as well as reductions in mast cell burden and KIT D816V variant allele frequency, in adult patients with advanced systemic mastocytosis.

The combination of pelabresib and ruxolitinib produced responses that proved to be durable beyond week 24 in patients with myelofibrosis who experienced a suboptimal response to ruxolitinib and in those who were JAK inhibitor naïve.

The combination of epcoritamab and R-CHOP produced high overall response rates and complete metabolic response rates with a manageable toxicity profile in patients with diffuse large B-cell lymphoma.

The triplet combination regimen comprised of quizartinib, decitabine, and venetoclax elicited encouraging responses in heavily pretreated patients with relapsed/refractory FLT3-ITD–mutated acute myeloid leukemia who were previously exposed to a FLT3 inhibitor.

Momelotinib demonstrated significant improvements in symptoms, spleen size, and anemia measures compared with danazol in patients with symptomatic and anemic myelofibrosis who previously received treatment with a JAK inhibitor.

The addition of quizartinib to standard induction and consolidation chemotherapy and then continued as a single agent doubled median overall survival vs standard chemotherapy alone in patients with newly diagnosed FLT3-ITD–positive acute myeloid leukemia.

Single-agent acalabrutinib continued to showcase favorable efficacy, with a notable benefit in progression-free survival benefit over standard-of-care regimens and a consistent toxicity profile, in patients with relapsed/refractory chronic lymphocytic leukemia.

The fixed-duration, frontline combination comprised of ibrutinib and venetoclax continued to produce deep, durable responses with a clinically meaningful progression-free survival benefit in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The European Commission has granted a conditional marketing authorization for mosunetuzumab for the treatment of adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 systemic therapies.

The global biopharmaceutical company Bristol Myers Squibb has announced the withdrawal of a supplemental biologics license application that was seeking the approval of luspatercept-aamt for the treatment of anemia in adults with non–transfusion dependent beta-thalassemia.

Resection of the primary tumor prior to systemic therapy was not found to extend overall survival in patients with asymptomatic colon and high rectal cancer who had synchronous unresectable metastases.

Zenocutuzumab was found to produce durable responses in patients with previously treated advanced NRG1-positive cancers, with antitumor activity observed across several tumor types, and to have an extremely well tolerated toxicity profile, according to data from a phase 1/2 trial (NCT02912949).

The selective EGFR inhibitor CLN-081 elicited objective responses in heavily pretreated patients with non–small cell lung cancer with EGFR exon 20 insertions and was found to have an acceptable toxicity profile, according to data from the phase 1/2a CLN-081-001 trial.

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.