Cancer Treatment Today

in July 2022, the Food and Drug Administration (FDA) recently approved the combination of the targeted drugs dabrafenib (Tafinlar) and trametinib (Mekinist) for the treatment of people with nearly any type of advanced solid tumor that has a specific mutation in a gene called BRAF.
This mutation, known as BRAF V600E, can increase the growth and spread of cancer cells.
The accelerated approval, announced on June 22, covers adults and children 6 years of age or older with BRAF V600E-positive tumors that cannot be removed by surgery or have spread to another part of the body (metastasized).
FDA previously approved the dabrafenib–trametinib combination for the treatment of people with advanced forms of specific cancers whose tumors have the BRAF V600E mutation, including non-small cell lung cancer, melanoma, and anaplastic thyroid cancer.
The FDA approval was based in part on results from adult patients with the BRAF V600E mutation enrolled in a substudy of NCI-MATCH. Participants had different tumor types, including ovarian cancers, gastrointestinal cancers, and cancers of the central nervous system. All of these showed that some of such cacner responded to these drugs.

Findings from the ROAR trial were also part of FDA’s analysis. Sponsored by GlaxoSmithKline and Novartis, ROAR enrolled adults with specific BRAF V600E mutation-positive solid tumors, including glioma and biliary tract cancer.
In a study published in 2020, researchers conducting the ROAR trial wrote that routine testing for the BRAF V600E mutation should be considered for all patients with biliary tract cancer. This study did not include people with GI cancers.

Subbiah V, Lassen U, Élez E, Italiano A, Curigliano G, Javle M, de Braud F, Prager GW, Greil R, Stein A, Fasolo A, Schellens JHM, Wen PY, Viele K, Boran AD, Gasal E, Burgess P, Ilankumaran P, Wainberg ZA. Dabrafenib plus trametinib in patients with BRAFV600E-mutated biliary tract cancer (ROAR): a phase 2, open-label, single-arm, multicentre basket trial. Lancet Oncol. 2020 Sep;21(9):1234-1243.

https://www.cancer.gov/news-events/cancer-currents-blog/2022/fda-dabrafenib-trametinib-braf-solid-tumors Accessed 9/30/2022

Alshammari K, Aung KL, Zhang T, Razak ARA, Serra S, Stockley T, Wang L, Nguyen J, Spreafico A, Hansen AR, Zwir D, Siu LL, Bedard PL. Phase II Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2021 Dec;20(4):334-341.

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