Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Drug Combination for Melanoma

Array BioPharma news release; 2018 Jun 27

Array BioPharma Inc. has announced that the US Food and Drug Administration (FDA) has approved Braftovi (encorafenib) capsules in combination with Mektovi (binimetinib) tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test. Braftovi is not indicated for the treatment of patients with wild-type BRAF melanoma. Array BioPharma Inc. is headquartered in Boulder, CO.

Dosage/administration for Braftovi: The recommended dose is 450 mg orally once daily in combination with Mektovi (binimetinib). Braftovi can be taken with or without food.

Dosage/administration for Mektovi: The recommended dose is 45 mg orally twice daily in combination with Braftovi. Mektovi can be taken with or without food. For patients with moderate or severe hepatic impairment the recommended dose is 30 mg orally twice daily.

Adverse reactions: The most common adverse reactions (>25%) for Braftovi, in combination with Mektovi, are fatigue, nausea, vomiting, and abdominal pain.


Array BioPharma announces FDA approval of Braftovi (encorafenib) in combination with Mektovi (binimetinib). [news release]. Boulder, Colorado: Array BioPharma Inc. June 27, 2018. Accessed June 27, 2018.

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Smoking, Not Alcohol, Linked with Psoriasis Risk, J Am Acad Dermatol; 2019 Mar; Dai, et al

Maternal Socioeconomic Position, Psoriasis Linked, Br J Dermatol; 2019 Feb; Groot, Nybo Andersen, et al

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Must Reads in FDA Actions

FDA Approves Hyrimoz for Plaque Psoriasis, Sandoz news release; 2018 Oct 31

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FDA Approves Nuzyra for Acute Skin Infections, Paratek Pharmaceuticals, Inc. news release; 2018 Oct 2

Psoriasis Treatment Receives Tentative FDA Approval, Bausch Heath news release; 2018 Oct 8

FDA Approves Libtayo for Metastatic cSCC, Sanofi news release; 2018 Sep 28