Cotellic

Cobimetinib

• Brand(s): Cotellic
• Dosage Form/Strength: 20 mg tablet

Initial criteria:

For the treatment of patients with previously untreated BRAF V600 mutation-positive unresectable stage Ill or stage IV melanoma who have a good performance status (ECOG ≤ 2).

• As first-line combination therapy with vemurafenib; AND

• If brain metastases are present, they should be asymptomatic or stable

Recommended Dose as combination dual therapy with Vemurafenib:
Cobimetinib 60 mg once daily for 21 days, followed by seven days off treatment; AND
Vemurafenib 960 mg twice daily for 28 days.
Both drugs are given until disease progression or unacceptable toxicity.

Renewal criteria:
Combination dual therapy may be continued until evidence of disease progression¹ or development of unacceptable toxicity requiring discontinuation.

¹Letter from physician outlining radiological and clinical benefit requiring continuation of the drug and verification of no disease progression or development of unacceptable toxicity must be submitted.

Approval duration (both initial and renewal requests): 6 months (patients should have their disease status assessed at least every 6 months)

Exclusion Criteria:

• BRAF V600 negative, or wild type tumors, or unknown status will not be funded

Cobimetinib therapy will not be considered for funding in patients who have progressed on a prior BRAF inhibitor therapy used as monotherapy or in combination.

EAP Drug Request Form:

Standard Form for EAP Drug Requests