Kristi Rosa

The combination of nivolumab and cabozantinib showcased significant benefit in terms of progression-free survival, overall survival, and responses vs sunitinib in the frontline treatment of patients with advanced renal cell carcinoma, as was underscored in data from the phase 3 CheckMate-9ER trial.

Poziotinib, when given at a daily dose of 16 mg, was found to demonstrate clinically meaningful activity when used in treatment-naïve patients with metastatic non–small cell lung cancer who harbor EGFR exon 20 mutations.

The filing of a biologics license application has been initiated with the FDA for toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.

The FDA has expanded the indication for lorlatinib to include the frontline treatment of patients with ALK-positive non–small cell lung cancer.

The treatment paradigm for chronic lymphocytic leukemia has expanded beyond continuous treatment with BTK inhibitors with the addition of the time-limited regimen of venetoclax plus obinutuzumab.

Health Canada has approved the BTK inhibitor zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia.

Merck has withdrawn pembrolizumab from the US market for the treatment of patients with metastatic small cell lung cancer who experienced disease progression on or after platinum-based chemotherapy and at least 1 previous line of treatment.

As more options emerge in the mantle cell lymphoma paradigm, choosing among the agents available has become all the more challenging.

A supplemental new drug application has been submitted to the FDA for ivosidenib tablets as a potential therapeutic option for patients with previously treated, IDH1-mutated cholangiocarcinoma.

The FDA has issued a complete response letter to Athenex, Inc. stating that it will not, at this time, approve the new drug application for oral paclitaxel in combination with encequidar for the treatment of patients with metastatic breast cancer.

The FDA has approved melphalan flufenamide for use in combination with dexamethasone in the treatment of select adult patients with relapsed/refractory multiple myeloma.

Natural killer cells can offer several advantages over T cells for CAR therapy in that the former uses both a CAR dependent and independent mechanism for tumor eradication, has better safety, and off-the-shelf feasibility—all at a potentially lower cost.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the combination of cabozantinib plus nivolumab for use as a frontline treatment in patients with advanced renal cell carcinoma.

The FDA has granted a breakthrough therapy designation to cabozantinib as a potential therapeutic option for patients with differentiated thyroid cancer that has progressed after previous therapy and who are refractory to radioactive iodine.

February 24, 2021 - The CAR T-cell product KTE-X19 continues to demonstrate durable clinical benefit in patients with relapsed/refractory mantle cell lymphoma, with an overall response rate of 92%.

February 24, 2021 - The FDA has granted a breakthrough therapy designation to tipifarnib for use in patients with recurrent or metastatic HRAS-mutated head and neck squamous cell carcinoma with variant allele frequency of 20% or higher following progressive disease on platinum-based chemotherapy.

Feburary 23, 2021 — The addition of the anti-CD20 monoclonal antibody ublituximab to ibrutinib led to a statistically higher overall response rate over ibrutinib alone with acceptable safety in patients with relapsed/refractory, high-risk, chronic lymphocytic leukemia.

February 23, 2021 - The FDA has approved the PD-L1 IHC 22C3 pharmDx assay, developed by Agilent Technologies Inc, for expanded use in patients with non–small cell lung cancer.

February 22, 2021 - The FDA has granted a fast track designation to the DNA-mediated interleukin-12 immunotherapy GEN-1 for use in the treatment of patients with advanced ovarian cancer.

February 22, 2021 - The FDA has granted priority review to a supplemental new drug application for ruxolitinib for use in adult and pediatric patients aged 12 years and older with steroid-refractory chronic graft-versus-host disease.

February 22, 2021 - The FDA has approved cemiplimab-rwlc monotherapy for use in the frontline treatment of patients with advanced non–small cell lung cancer with a PD-L1 expression level of 50% or higher.

AstraZeneca has voluntarily withdrawn durvalumab from the US market for the treatment of adult patients with locally advanced or metastatic bladder cancer.

February 19, 2021 - The National Comprehensive Cancer Network has issued guidelines for the management of children with a rare type of kidney cancer referred to as Wilms Tumor, or nephroblastoma.

February 18, 2021 - Single-agent cemiplimab has been found to result in a significant improvement in overall survival and progression-free survival versus chemotherapy in patients with advanced non–small cell lung cancer who had a PD-L1 expression of at least 50%.

February 18, 2021 - Two supplemental biologics license applications have been submitted to the FDA for enfortumab vedotin-ejfv to convert the agent’s accelerated approval into a regular one and to expand the current label to include patients with locally advanced or metastatic urothelial cancer who had received prior treatment with a PD-1/PD-L1 inhibitor and are not eligible for cisplatin.

February 18, 2021 — The use of next-generation sequencing demonstrated that 34% of patients with sarcoma had potentially actionable mutations.

February 17, 2021 - An independent data monitoring committee has concluded that the phase 3 OlympiA trial examining olaparib crossed the superiority boundary for its primary end point of invasive disease-free survival in patients with germline BRCA-mutated, high-risk, HER2-negative early breast cancer.

February 17, 2021 - The FDA has accepted and granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.

February 17, 2021 — The FDA has accepted a supplemental new drug application of zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia.

February 16, 2021 - The FDA has granted priority review to sotorasib for the treatment of patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer, after at least 1 previous systemic therapy