News

Here is a look back at the FDA happenings from the month of February 2021.

The FDA has issued a complete response letter to Athenex, Inc, regarding the New Drug Application for oral paclitaxel in combination with encequidar for the treatment of metastatic breast cancer. The FDA stated that the application review process has been completed, but the NDA is not ready for approval due to safety and efficacy concerns.

The FDA has issued an emergency use authorization for a third vaccine, the Janssen COVID-19 Vaccine, for the prevention of COVID-19 caused by SARS-CoV-2.

The FDA has granted approval to melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

The first patient has been dosed in the phase 1/2 clinical trial of an oral CDK9 inhibitor targeting MYC-amplified solid tumors known as KB-0742.

The rising prevalence of thyroid cancer and thyroid nodules, especially for differentiated thyroid cancer, has brought into question the management of disease as it is known today.

Hossein Borghaei, DO, MS, discusses some adverse events (AEs) associated with the use of immunotherapy for lung cancer.

The FDA has granted Breakthrough Therapy Designation to cabozantinib for the potential treatment of patients with differentiated thyroid cancer that has progressed following prior therapy and who are radioactive iodine-refractory if eligible for radioactive iodine.

Sergio Giralt, MD, discusses the current unmet medical needs for patients with relapsed/refractory acute myeloid leukemia.

The Centers for Medicare & Medicaid Services have found that there is sufficient evidence for the coverage of blood-based biomarker tests to be granted for patients with colorectal cancer once every 3 years or at a specific individual test interval labeled by the FDA.

The FDA has granted a Breakthrough Therapy Designation to tipifarnib for the treatment of patients with recurrent or metastatic HRAS-mutant head and neck squamous cell carcinoma with variant allele frequency ≥ 20% after disease progression on platinum-based chemotherapy.

A preplanned analysis of the Regorafenib Dose Optimization Study in patients with metastatic colorectal cancer showed using pre-emptive clobetasol to treat hand–foot skin reactions was more effective than treating this adverse event reactively.

Three of the country’s leading health and cancer advocacy groups released recommendations on how to close the gap in racial health care disparities, which include increasing community engagement, improving access to care, addressing bias in care delivery, and providing quality and comprehensive care.

A promising efficacy signal was observed when the immune checkpoint inhibitor durvalumab was added concurrently to radiation followed by adjuvant durvalumab as treatment of patients with localized urothelial bladder cancer.

For the treatment of relapsed or refractory aggressive B-cell lymphomas, chimeric antigen receptor–modified T-cell therapy is becoming more widely used. Still, little is known about outcomes for patients who receive CAR-modified T-cell therapy beyond 2 years.

The National Comprehensive Cancer Network released the first set of guidelines for pediatric patients with nephroblastoma for oncologists and primary care physicians.

The FDA has expanded the use of PD-L1 IHC 22C3 pharmDx assay to include the diagnosis of patients with non-small cell lung cancer, announced the developer, Agilent Technologies, Inc.

Shana Wingo, MD, talks about the challenges of treating patients in the Greater Phoenix, Arizona area.

A novel DNA-mediated interleukin-12 immunotherapy, GEN-1, had been granted a Fast Track designation by the FDA for the treatment of advanced ovarian cancer.

In an interview with Targeted Oncology, Shana N. Wingo, MD, discussed how the opening of Cancer & Blood Specialists of Arizona will help to serve the greater Phoenix area and how its partnership with AON will improve cancer care in the area.

The FDA has accepted a supplemental New Drug Application for ruxolitinib and granted it Priority Review as a potential treatment option for adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease.

In an interview with Targeted Oncology, Shaakir Hasan, DO, discussed the results found when diagnostic and treatment information from patients with bladder cancer was prospectively assessed. He also discussed future work on disparities in health care in an interview with Targeted Oncology.

The durvalumab indication as a treatment for previously treated adult patients with locally advanced or metastatic bladder cancer has been voluntarily withdrawn in the United States by AstraZeneca, the developer of the PD-L1 inhibitor, the company announced in a press release.

Enrollment of patients with relapsed or refractory follicular lymphoma in a phase 2 LYMRIT 37-01 PARADIGME study of third-line Lu lilotomab satetraxetan has increased accrual to 2-5 patients per month.

Tisagenlecleucel induced a significant number of complete responses in patients with relapsed or refractory follicular lymphoma, meeting the primary end point of the phase 2 ELARA trial as of the interim analysis of the study.

The FDA has granted approval to cemiplimab-rwlc, for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression, as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK, or ROS1 aberrations.

Data from patients with relapsed/refractory diffuse large B-cell lymphoma treated with axicabtagene ciloleucel showed that post-chimeric antigen receptor T outcomes may not correlate with responsiveness observed with treatment received immediately prior.

Final analysis results from the phase 3 IMpower110 trial show the benefit of atezolizumab over chemotherapy in a non–small cell lung cancer subgroup.

Omidubicel was faster than standard myeloablative umbilical cord blood transplantation and correlated with promising clinical benefit, according to phase 3 data.

Adjuvant imatinib has demonstrated significant improvement in relapse-free survival over a 2-year period and a mild trend toward long-term improvement in failure-free survival as treatment of patients with high-risk gastrointestinal stromal tumors, according to 9.1-year follow-up results from a randomized phase 3 study.