FDA approved Cotellic (cobimetinib) for BRAF V600 Melanoma and Histiocytic NeoplasmsFDA approved new drug Cotellic for certain skin and blood cancers

FDA From the archive Source published November 10, 2015 Summary added August 25, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider confirming BRAF V600E/K mutation before starting Cotellic with vemurafenib for melanoma.

The FDA has approved Cotellic (cobimetinib), a kinase inhibitor, for the treatment of adult patients with unresectable or metastatic melanoma harboring BRAF V600E or V600K mutations, in combination with vemurafenib. Additionally, Cotellic is approved as a single agent for adult patients with histiocytic neoplasms. This approval provides a new targeted therapy option for these patient populations.

For melanoma, the approval is based on clinical evidence demonstrating efficacy when combined with vemurafenib. The label specifies that confirmation of BRAF V600E or V600K mutation in tumor specimens is required prior to initiation of therapy. For histiocytic neoplasms, the approval is based on data from clinical studies, though specific trial outcomes are not detailed in the label.

Clinicians should note the recommended dosing schedule and the need for dose modifications in the event of adverse reactions or concurrent use of moderate CYP3A inhibitors. The approval expands therapeutic options for these challenging conditions.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Cotellic (cobimetinib) is a kinase inhibitor. It inhibits the activity of MEK, a protein kinase involved in the MAPK signaling pathway, which is often dysregulated in BRAF-mutant tumors.

Indication & Patient Population

Cotellic is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. It is also indicated as a single agent for the treatment of adult patients with histiocytic neoplasms.

Dosing & Administration

The recommended dose is 60 mg (three 20 mg tablets) orally once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity. Cotellic can be taken with or without food. If a dose is missed or vomiting occurs, resume with the next scheduled dose. Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of Cotellic with vemurafenib for melanoma.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Dose modifications are required for adverse reactions including hemorrhage, cardiomyopathy, dermatologic reactions, serous retinopathy or retinal vein occlusion, liver laboratory abnormalities, rhabdomyolysis and CPK elevations, photosensitivity, and other severe reactions. Concurrent use of strong or moderate CYP3A inhibitors should be avoided. If short-term use of moderate CYP3A inhibitors is unavoidable, reduce Cotellic dose to 20 mg. Contraindications are not explicitly listed in the label.

Place in Therapy

Cotellic provides a targeted treatment option for BRAF V600-mutant melanoma when used in combination with vemurafenib, and as a single agent for histiocytic neoplasms. It should be used in appropriate patient populations as described in the label.

The U.S. Food and Drug Administration (FDA) has approved a new drug called Cotellic (cobimetinib). It is a type of medicine called a kinase inhibitor. This drug is for two different conditions: advanced melanoma (a serious skin cancer) and a group of rare diseases called histiocytic neoplasms, which affect certain immune cells.

For melanoma, Cotellic is used together with another drug called vemurafenib. It is only for adults whose tumors have a specific change in a gene called BRAF, either V600E or V600K. Before starting treatment, doctors must test the tumor to confirm this gene change. For histiocytic neoplasms, Cotellic is used alone.

The approval is based on studies showing that the drug helps patients with these conditions. For melanoma, the combination treatment has been shown to be effective. For histiocytic neoplasms, the approval is based on clinical study data, though the label does not give specific results.

This approval gives patients more options, but it is not a cure for everyone. The drug can have side effects, and the dose may need to be adjusted if you have certain other medicines or side effects. If you or a loved one has one of these conditions, talk to your doctor to see if Cotellic might be an option. Your doctor can explain the benefits and risks based on your specific situation.

What this means for you:

Cotellic is a new targeted option for certain advanced melanomas and rare blood cancers, but only for patients with specific gene changes or diagnoses.

Study Details

Study typeFda approval

PublishedNov 2015

View Original Abstract ↓

1 INDICATIONS AND USAGE COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. 1.2 Histiocytic Neoplasms COTELLIC®, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.

FDA approved Cotellic (cobimetinib) for BRAF V600 Melanoma and Histiocytic NeoplasmsFDA approved new drug Cotellic for certain skin and blood cancers

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FDA approved Cotellic (cobimetinib) for BRAF V600 Melanoma and Histiocytic NeoplasmsFDA approved new drug Cotellic for certain skin and blood cancers

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