5 FDA Cancer Drug Approvals for Solid Tumors That Patients May Have Missed

Several cancer treatments received approvals from the Food and Drug Administration (FDA) in the spring.

The FDA approvals were indicated for drug combinations to treat solid tumors with certain genetic characteristics, as well as a biosimilar to treat neutropenia (lower-than-normal levels of neutrophils, which is a type of white blood cell).

Here, CURE® provides a rundown of the newer cancer therapies that the FDA approved this spring:

• Tafinlar (dabrafenib) plus Mekinist (trametinib) for patients over the age of 6 with unresectable or metastatic BRAF V600E-mutant solid tumors. The approval is for patients who have already experienced disease progression and have no other treatment options. Findings from the phase 2 ROAR trial, which led to the drug duo’s approval, showed that 80% of patients had their tumors shrink after taking Tafinlar plus Mekinist.
• Fylnetra (pegfilgrastim-pbbk) for the prevention of neutropenia in patients with cancer. Fylnetra is a biosimilar — meaning that it has no clinically meaningful differences in outcomes — to Neulasta. The drug, which is made from living organisms, was approved for patients with non-myeloid malignancies who are receiving myelosuppressive treatment which often puts individuals at an increased risk of febrile neutropenia.
• Opdivo (nivolumab) plus fluoropyrimidine- and platinum-containing chemotherapy, as well as Opdivo plus Yervoy (ipilimumab) for patients with esophageal squamous cell carcinoma. The two immunotherapy-based regimens were approved regardless of patients’ PD-L1 status and led to improved progression-free survival (time from treatment until disease worsens) in the clinical trials leading up to the regimen’s approvals.
• Enhertu (fam-trastuzumab – deruxtecan-nxki) for patients with unresectable or metastatic HER2-positive breast cancer who have previously been treated with a HER2-based regimen. Findings from the DESTINY-Breast03 trial, which led to the drug’s approval, showed that Enhertu led to a 72% reduced risk of disease progression or death for this patient population.
• Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer. This is the first targeted radioligand therapy approved for this patient population and led to a four-month improvement of average overall survival compared to standard of care.

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