Dr. Richard Pazdur, director of the Food and Drug Administration’s Oncology Center of Excellence, has noted that the agency is committed to expediting oncology drug development despite the challenges posed by the COVID-19 pandemic.
CURE® has compiled a list of some of the most recent drug approvals from the Food and Drug Administration (FDA) that patients may have missed as the agency indicates its commitment to continue to review cancer treatments while also addressing the COVID-19 pandemic.
FDA Approves Imbruvica, Rituxan Combination in Previously Untreated Patients with CLL and SLL
The FDA recently approved the expanded use of Imbruvica (ibrutinib) in combination with Rituxan (rituximab) for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
“The gold-standard first-line treatment option for many patients with chronic lymphocytic leukemia who were fit enough to tolerate an aggressive treatment course had been the intravenous chemoimmunotherapy of FCR — that is, until today,” Dr. Brian Koffman, CLL Society co-founder, executive vice president and chief medical officer, said in a press release from the drug’s manufacturer. “The FDA approval of ibrutinib and rituximab regimen is welcome news for these previously untreated patients who have been looking forward to a non-chemotherapy treatment option.” READ MORE.
Tukysa Approved to Treat Advanced or Metastatic HER2-Positive Breast Cancer
The targeted drug Tukysa (tucatinib) was recently approved in combination with other medications to treat adults with HER2-positive breast cancer that can’t be removed surgically, or has spread other parts of the body, and who have received one or more prior therapies for metastatic disease.
The approval was based on findings from a clinical trial that included 612 patients with advanced or metastatic HER2-positive breast cancer, including some whose disease had spread to the brain. Patients who took the Tukysa combination went a median 7.8 months before experiencing disease progression, compared with 5.6 months in patients in the two-drug group. In the Tukysa group, the median overall survival was 21.9 months compared with 17.4 months in the placebo/Herceptin/capecitabine group. READ MORE.
FDA Approves Pemazyre to Treat Advanced Cholangiocarcinoma
The first drug designed to treat patients with previously treated, advanced cholangiocarcinoma who have tumors that have a fusion or other rearrangement of FGRF2 was recently approved.
“With Pemazyre, we considered the observed efficacy results to be clinically meaningful and the overall risk to benefit assessment for patients with tumors harboring FGFR2 gene fusions and other rearrangements to be favorable, particularly when we considered that these patients have no other good options following first line treatment with chemotherapy,” Pazdur said in a press release. READ MORE.
FDA Approves Trodelvy for Pretreated Metastatic Triple-Negative Breast Cancer
The FDA recently approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.
The approval was made under the FDA’s Accelerated Approval Program based on results from a single-arm, multicenter phase 2 study. Continued approval may depend upon verification of clinical benefit in the confirmatory phase 3 ASCENT study, which was recently stopped early due to very promising results to review. READ MORE.
First Low-Grade Upper Tract Urothelial Cancer Therapy Receives FDA Approval
Jelmyto (mitomycin gel), the first drug to treat patients with low-grade upper tract urothelial cancer, a cancer of the lining of the urinary system, was recently approved by the FDA.
“Due to substantial treatment challenges associated with the complex anatomy of the upper urinary tract, many patients need to be treated with radical surgery — usually complete removal of the affected kidney, ureter and bladder cuff. Jelmyto gives patients, for the first time, an alternative treatment option for low-grade UTUC,” Pazdur said in a press release. READ MORE.