A combination cancer treatment has been expanded to include treating both melanoma and anaplastic thyroid cancer (ATC).
A combination cancer treatment has been expanded to include treating both melanoma and anaplastic thyroid cancer (ATC).
FDA recently approved Novartis’s dabrafenib (Tafinlar) and trametinib (Mekinist), administered together, for the treatment of metastatic ATC, which has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive). The combo drug was also approved for patients with melanoma, with BRAF V600E or V600K mutations and involvement of lymph node(s), following complete resection.
Related: New lung cancer drug gains approval, plus 2 more
“This is the first FDA-approved treatment for patients with this aggressive form of thyroid cancer, and the third cancer with this specific gene mutation that this drug combination has been approved to treat,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, in an FDA statement. “This approval demonstrates that targeting the same molecular pathway in diverse diseases is an effective way to expedite the development of treatments that may help more patients.”
"Since the initial approval of Tafinlar and Mekinist in metastatic melanoma in 2013, the combination has become an important therapy for many patients carrying a BRAF mutation in both melanoma and lung cancers," said Liz Barrett, CEO of Novartis Oncology, in a Novartis statement.
Related: FDA approves revolutionary blood cancer treatment
The efficacy of Tafinlar and Mekinist in treating ATC was shown in an open-label clinical trial of patients with rare cancers with the BRAF V600E mutation. The trial measured the percent of patients with a complete or partial reduction in tumor size (overall response rate). Of 23 evaluable patients, 57% experienced a partial response and 4% experienced a complete response. In 64% of the 14 patients with responses, there were no significant tumor growths for six months or longer.
Meanwhile, the melanoma approval is based on results from a phase 3 study of 870 patients with Stage 3 BRAF V600E/K mutation-positive melanoma treated with Tafinlar and Mekinist after complete surgical resection. Treatment with the combination therapy significantly reduced the risk of disease recurrence or death by 53%.
Improvements were also observed in key secondary end points including overall survival, distant metastasis-free survival and freedom from relapse.
Read more: First direct-to-consumer test for breast cancer risk hits market
Get the latest industry news, event updates, and more from Managed healthcare Executive.
PBM-Offered Genomics Testing Could Reshape Prescribing of Medications
July 25th 2025Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.
Read More
FDA Extends Review of Blenrep Combinations in Multiple Myeloma
July 24th 2025Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
Read More
Sarepta to Pause Shipments of the Gene Therapy Elevidys
July 22nd 2025Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
Read More