Kristi Rosa

The FDA has granted a fast track designation to the soluble LAG-3 protein eftilagimod alpha for use in the frontline treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.

Single-agent pembrolizumab resulted in a significant improvement in disease-free survival when used as an adjuvant treatment in patients with renal cell carcinoma following nephrectomy or nephrectomy and resection of metastatic lesions, meeting the primary end point of the phase 3 KEYNOTE-564 trial.

The combination of nivolumab and ipilimumab and nivolumab plus chemotherapy resulted in a statistically significant overall survival benefit compared with chemotherapy alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.

The FDA has recommended the early termination of a phase 2 trial examining the cell-based immunotherapy ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, cyclophosphamide, and bevacizumab in patients with glioblastoma.

The FDA has granted a regular approval to sacituzumab govitecan for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have previously received 2 or more systemic therapies, at least 1 of them for metastatic disease.

The FDA has approved a new biweekly dosing regimen of 500 mg/m2 as a 120-minute intravenous infusion for cetuximab (Erbitux) for patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck.

The RET inhibitor TPX-0046 demonstrated encouraging preliminary activity, which included objective responses, and an acceptable toxicity profile when used in patients with RET-driven advanced solid tumors.

The rolling submission of a biologics license application to support the approval of the investigational BCMA-directed CAR T-cell therapy ciltacabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma has been completed.

The multitumor-associated antigen-specific T-cell product MT-401 is under investigation as a potential treatment option for patients with acute myeloid leukemia following allogeneic stem cell transplant in both the adjuvant and active disease settings.

The HER3-directed antibody-drug conjugate patritumab deruxtecan is under exploration in the treatment of patients with EGFR-mutated, metastatic or locally advanced non–small cell lung cancer who had previously received a TKI and platinum-based chemotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of single-agent duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia following at least 2 prior therapies, and follicular lymphoma that is refractory to at least 2 prior systemic treatments.

The FDA has granted a breakthrough therapy designation to the FGFR inhibitor futibatinib for the treatment of patients with previously treated, locally advanced or metastatic cholangiocarcinoma that harbors FGFR2 gene rearrangements, including fusions.

A new drug application has been submitted to the FDA and the China National Medical Products Administration for the use of plinabulin plus granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

The FDA has approved isatuximab in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received 1 to 3 lines of therapy.

A biologics license application has been submitted to the FDA for the approval of F-627 as a treatment option for patients with breast cancer who have chemotherapy-induced neutropenia.

The rolling submission of a new drug application has been completed and submitted to the FDA to support the approval of pacritinib as a treatment for patients with myelofibrosis and severe thrombocytopenia defined as having platelet counts less than 50 x 109/L.

The European Commission has approved the combination of cabozantinib plus nivolumab for use as a frontline treatment in patients with advanced renal cell carcinoma.

The FDA has approved a revised label for daunorubicin/cytarabine (Vyxeos) to include the treatment of pediatric patients aged 1 year and older with newly diagnosed, therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes.

The FDA has granted a fast track designation for annamycin as a treatment for patients with soft tissue sarcoma lung metastases.

The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines to include tivozanib as a recommended regimen for subsequent therapy in patients with clear cell renal cell carcinoma.

Gilteritinib was found to result in a significant improvement in overall survival when used in patients with FLT3-mutated, relapsed/refractory acute myeloid leukemia, meeting the primary end point of the confirmatory phase 3 COMMODORE trial in China.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of recommending that the label for pembrolizumab in Europe be updated to include findings from the phase 3 KEYNOTE-361 trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion to recommend an additional indication of enzalutamide for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.

The FDA has issued a complete response letter to Merck stating that regulatory decision for the supplemental biologics license application seeking approval for pembrolizumab for use in patients with high-risk, early-stage triple-negative breast cancer plus chemotherapy as neoadjuvant treatment, then continuing as a single agent as adjuvant treatment following surgery, should be deferred.

The European Commission has granted conditional marketing authorization for selinexor for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have previously received at least 4 therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody, and have experienced progressive disease on their last therapy.

The European Medicines Agency has validated its type II variation application for nivolumab as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.

The rolling submission of a biologics license application to support the approval of ublituximab plus umbralisib as a treatment for patients with chronic lymphocytic leukemia has been completed.

Osimertinib (Tagrisso) showcased encouraging efficacy and acceptable safety in patients with EGFR-positive, advanced non–small cell lung cancer. according to real-world findings from an observational, multicenter study.

Previous exposure to immune checkpoint inhibitors or osimertinib has been linked with poor outcomes in patients with non–small cell lung cancer who were receiving a subsequent atezolizumab-containing regimen.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of atezolizumab for use as a frontline treatment in adult patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and no EGFR or ALK aberrations.