Ready to challenge Novartis and Roche, Array scores FDA nod for melanoma combo

Twenty years after it began, Array BioPharma has its first two drug approvals, a cancer drug combo that'll transform care for certain melanoma patients, the company's CEO says. But they'll face a couple of heavyweight pharmas in the field.

The combo of Mektovi, a MEK inhibitor, and Braftovi, a BRAF inhibitor, won FDA approval to treat patients with melanoma that can't be surgically removed or has spread through the body, provided the tumors have BRAF V600E or V600K mutations. According to AIM at Melanoma Foundation co-founder and president Valerie Guild, nearly half of metastatic melanoma patients test positive for the mutation.

Data from a phase 3 trial against Roche's Zelboraf, which showed Array's combo beat the Roche drug in patients with BRAF-mutant melanoma, supported the approval. Patients on the Array combo had a median overall survival of 33.6 months, compared with 16.9 months for Roche's Zelboraf. 

In a statement Wednesday, Array CEO Ron Squarer said the drugs will fill a "critical unmet need" and "represent a new standard of care" for the patients.

In the market, the drugs will challenge Novartis' combo of Tafinlar and Mekinist and Roche's combo of Zelboraf and Cotellic. Both Big Pharma companies are practiced at oncology marketing and their drugs have the advantage of a head start. But in an interview last month, Squarer told FiercePharma that Array's size gives it some advantages.

"As a smaller company, we are excited about working to make the patient experience as good as possible," he said, adding that there's a "very concentrated group of prescribers," so the small biotech will be able to cover the ground with a small field force. 

In preparing for the launch, the company already had about 60 customer-facing employees supporting the drug, he said, including sales representatives, medical affairs staff and a payer-focused team. Array also has assistance programs that will cut copays to zero for patients with commercial insurance, and it's working to make sure patients can access the drugs quickly. 

The combo is now available through certain specialty pharmacies, according to the company.

Array's path to its first approval wasn't without speed bumps. Founded 20 years ago, Array previously sought approval for Mektovi to treat NRAS-mutant melanoma, but the company pulled the application last year after the FDA said efficacy data weren't strong enough. Now, Array has its first two drug approvals on the same day.

The biotech is also developing ARRY-797 to treat a rare cardiovascular disease called LMNA-related DCM, and ARRY-382 in combo with Merck's Keytruda in a study against advanced solid tumors, among other programs. 

Aside from the U.S., Array also has Canadian rights to the combo. Ono Pharmaceutical has rights in Japan and South Korea, while Pierre Fabre has rights elsewhere in the world, including in Europe, Latin America and Asia.