2021 was full of research advancements and FDA drug approvals that continue to improve cancer care for patients with a variety of malignancies.
From immunotherapy combinations to treatments for the complications that can arise from stem cell transplantation, the year 2021 brought countless Food and Drug Administration (FDA) approvals that are changing patients’ lives.
CURE® made a roundup of some of the most-read FDA approvals throughout the year. They were:
In August, the FDA approved Welireg (belzutifan) for adults with von Hippel-Lindau (VHL)-related kidney cancer, central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumors (pNET) that do not require immediate surgery. The drug led to response rates in 49% of patients with kidney cancer, 63% of CNS hemangioblastoma and 83% of pNET.
Keytruda (pembrolizumab), an immunotherapy agent, plus chemotherapy was approved for patients with high-risk, early-stage triple-negative breast cancer (TNBC) — an advancement that “has the potential to change the treatment paradigm,” according to Dr. Joyce O’Shaughnessy.
This March, the FDA approved Yescarta (axicabtagene ciloleucel), for pretreated indolent (low-grade) follicular lymphoma — the first CAR-T cell therapy to be approved in this patient population. The ZUMA-5 clinical trial led to the drug’s approval and showed that 91% of patients with relapsed/refractory follicular lymphoma were in continued remission at 18 months post treatment.
TheraSphere™ Yttrium-90 (Y-90) Glass Microspheres was granted FDA approval for patients with hepatocellular carcinoma — the most common type of liver cancer. The approval is notable because it allowed an option for this patient population to be treated without being hospitalized.
Individuals with chronic graft-versus-host disease (GVHD) that was previously treated with at least two other therapy now have a new treatment option — Rezurock (belumosudil) — thanks to the FDA’s approval of the agent this summer. “Rezurock has shown robust and durable responses across the spectrum of (chronic graft-versus-host disease) and is safe and well tolerated, allowing patients to stay on therapy and achieve meaningful benefit from treatment,” said Dr. Corey Cutler.
In March, the FDA approved the first cell-based gene therapy — Abecma (idecabtagene vicleucel) — for the treatment of adults with multiple myeloma who did not respond to at least four lines of therapy or whose disease returned after the same number of therapies.
Cabometyx (cabozantinib) was given the greenlight by the FDA for the treatment of patients with previously treated radioactive iodine-refractory differentiated thyroid cancer.
The agency approved Lumakras (sotorasib), the first targeted therapy for patients with non-small cell lung cancer and a KRAS G12C mutation, whose disease progressed after one systemic therapy.
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