Noted This Week
The FDA approved several drugs for new indications and in new combinations, including:
- the VEGFR2 inhibitor ramucirumab (Cyramza; Eli Lilly) for patients with hepatocellular carcinoma who have an alpha fetoprotein level of at least 400 ng/mL, and who have previously been treated with the tyrosine kinase inhibitor sorafenib (Nexavar; Bayer/Onyx)
- the PD-L1 inhibitor avelumab (Bavencio; EMD Serono) plus the VEGFR inhibitor axitinib (Inlyta; Pfizer) for first-line treatment of advanced renal cell carcinoma
- the BCL2 inhibitor venetoclax (Venclexta; AbbVie) plus the anti-CD20 antibody obinutuzumab (Gazyva; Genentech) as a first-line therapy for chronic lymphocytic leukemia or small lymphocytic leukemia
The agency also granted an orphan drug designation to P-BCMA-101 (Poseida Therapeutics) for relapsed/refractory multiple myeloma. The investigational agent is an autologous CAR T therapy composed of self-renewing stem cell memory T cells that target B-cell maturation antigen (BCMA) on cancer cells. Researchers are testing the therapy in a phase II trial.
Celgene’s immunomodulatory agent lenalidomide (Revlimid) may reduce the risk of smoldering multiple myeloma developing into multiple myeloma, according to findings presented during a media preview for the 2019 American Society of Clinical Oncology Annual Meeting. In the phase III E3A06 trial, patients treated with the drug for 3 years had a progression-free survival rate of 91%, compared with 66% in patients who did not receive treatment. However, 51% of patients discontinued the drug due to side effects.
An FDA advisory panel voted 8–3 against the approval of quizartinib (Daiichi Sankyo), a FLT3 inhibitor, as a treatment for patients with relapsed/refractory FLT3-mutant acute myeloid leukemia. The new drug application was submitted based on the findings of the phase III QuANTUM-R trial, in which the drug extended median overall survival by 1.5 months compared with chemotherapy. The panel members said that the results were not strong enough to merit approval; the FDA will make a final decision by August 25, 2019.
Advaxis announced that the FDA lifted a partial hold on the cancer vaccine axalimogene filolisbac (Axal) after the company provided additional information about the vaccine’s chemistry, manufacturing, and control groups in the phase III AIM2CERV trial. The company can now continue enrolling patients in the trial, which is testing the vaccine in cervical cancer.
The U.S. Court of Appeals for the Federal Circuit voted to uphold a Novartis patent on everolimus, the active ingredient in the chemotherapy drug Afinitor. The decision follows a 2017 ruling against West-Ward Pharmaceuticals, now known as Hikma Pharmaceuticals USA, which claimed the patent was invalid. West-Ward was seeking approval to develop a generic version of the drug for advanced renal cell carcinoma.
The NCI awarded nearly $11 million to the Hollings Cancer Center of the Medical University of South Carolina in Charleston and renewed it as an NCI-designated cancer center following its 5-year review. Hollings is one of 70 NCI-designated cancer centers—and the only one in South Carolina. Over the past 5 years, the center has opened 392 research studies and enrolled 3,522 patients in clinical trials.