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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	encorafenib + binimetinib
Trade Name:
Date Designated:	11/19/2013
Orphan Designation:	Treatment of Stage IIB-IV melanoma positive for the BRAF mutation.
Orphan Designation Status:	Designated/Approved
Sponsor:	Array BioPharma, Inc. 100 Cambridgepark Drive Suite 505 Cambridge, Massachusetts 02140 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	encorafenib + binimetinib
	Trade Name:
	Marketing Approval Date:	06/27/2018
	Approved Labeled Indication:	MEKTOVI® is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test
	Exclusivity End Date:	06/27/2025
	Exclusivity Protected Indication* :	BRAFTOVI¿ (encorafenib) and MEKTOVI® (binimetinib) indicated, in combination, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

2	Generic Name:	encorafenib + binimetinib
	Trade Name:
	Marketing Approval Date:	06/27/2018
	Approved Labeled Indication:	BRAFTOVI¿ is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test
	Exclusivity End Date:	06/27/2025
	Exclusivity Protected Indication* :	BRAFTOVI¿ (encorafenib) and MEKTOVI® (binimetinib) indicated, in combination, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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