Product
Zelboraf

Approval Date
August 17, 2011

Release Date
August 30, 2011

Company
Roche/Daiichi Sankyo

Class
Oral, small molecule kinase inhibitor

Indication
For patients with unresectable (inoperable) or metastatic melanoma with a BRAF V600E mutation

Active Ingredient
Vemurafenib

Agency Roster
Harrison & Star

Marketing Strategy/Execution
Three sales forces, including one each from Roche and its Molecular Diagnostics Business, are looking to penetrate the melanoma market for patients with BRAF mutations. Zelboraf was approved with a companion diagnostic, the BRAF cobas test, allowing Roche to differentiate its novel skin cancer med from the other main competitor in the market, Bristol-Myer’s Squibb’s ipilimumab. The third sales force behind Zelboraf is a contract sales organization hired by Daiichi Sankyo, as it works to build out its oncology marketing and promotion organization in the US. The specialty firm acquired Zelboraf co-developer Plexxikon this year and with it co-promotion rights for the drug. Roche, which books 80% of sales, is keeping its marketing strategy details close to the vest but has said it will study Zelboraf in combination with ipilimumab in patients with BRAF mutation-positive metastatic melanoma under a clinical collaboration.

Physician Outlook
Zelboraf is the first ever drug for inoperable or metastatic melanoma approved by the FDA, together with an accompanying diagnostic test. The test allows physicians to identify patients with a specific mutation of the BRAF protein, which is found in about half of the patients with this devastating disease. Standard diagnostic procedures will soon be adapted with the BRAF mutation test in order to offer eligible patients Zelboraf as a promising new treatment option. Personalized medicine is moving closer to becoming a reality and hopes are high that patients with other cancers who also have this mutation might profit from this drug in the future.

-Petra Maertens, director of syndicated studies, oncology, GfK HealthCare

Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: GSK 2132231A
Manufacturer: GlaxoSmithKline
Indication: Malignant melanoma
Active ingredient: Astuprotimut-R
Phase: III

Drug: 2118436
Manufacturer: GlaxoSmithKline
Indication: Malignant melanoma
Active ingredient: Dabrafenib
Phase: III

Drug: Tasigna
Manufacturer: Novartis
Indication: Malignant melanoma
Active ingredient: Nilotinib
Phase: III

Drug: G 3139
Manufacturer: Genta
Indication: Malignant melanoma
Active ingredient: Oblimersen
Phase: III

Drug: OncoVEXGM-CSF
Manufacturer: BioVex
Indication: Malignant melanoma
Active ingredient: Talminogene laherparepvec
Phase: III

Drug: NEO3-09
Manufacturer: Neoprobe
Indication: Malignant melanoma
Active ingredient: Tc 99m tilmanocept
Phase: Preregistration

Drug: GSK-1120212B
Manufacturer: GlaxoSmithKline
Indication: Malignant melanoma
Active ingredient: Trametinib
Phase: III

Drug: Allovectin
Manufacturer: Abic
Indication: Malignant melanoma
Active ingredient: Velimogene aliplasmid
Phase: III (Fast Track)

Drug: G-200
Manufacturer: Medison
Indication: Malignant melanoma
Active ingredient: Vitespen
Phase: III (Fast Track)

Source: Wolters Kluwer Pharma Solutions

Recent MM&M Coverage
Therapeutic Focus: Oncology

Pharmacology
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Clinical Trials
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Adverse Reactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Adults
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Children
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Precautions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.