Array BioPharma gets FDA Approval for Melanoma Combo

June 28, 2018  Source: FiercePharma 185

The U.S, Based Array BioPharma received FDA approval for its much-awaited BRAFTOVI capsules with the combination of MEKTOVI tablets for the treatment of patients with metastatic melanoma with a BRAFV600E or BRAFV600K mutation.

Array CEO Ron Squarer said the drugs will fill a "critical unmet need" and "represent a new standard of care" for the patients. But they'll face a couple of pharma giants in the field.

Phase 3 trial data showed Array's combo beat the Roche Zelboraf drug in patients with BRAF-mutant melanoma, supported the approval. Patients on the Array combo had a survival of 33.6 months, compared with 16.9 months for Zelboraf, Roche's drug

In the market, the Array Biopharma combo will challenge Zelboraf and Novartis' combo of Tafinlar and Mekinist. Both Pharma companies are practiced at oncology marketing and their drugs have the advantage of a head start.

CEO, Squarer said ‘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", 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.

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

Array, which was founded 20 years ago, previously sought approval for Mektovi to treat NRAS-mutant melanoma, but the company pulled back the application last year after the FDA said efficacy data weren't strong. Now the company had its first two drug approvals on the same day.

By Ddu

your submission has already been received.



Please enter a valid Email address!


The most relevant industry news & insight will be sent to you every two weeks.

Warning: mysqli_query(): (HY000/1194): Table 'wp_posts' is marked as crashed and should be repaired in /data/www/ddu_2017/webapp/channel_drugdu_com/wp-includes/wp-db.php on line 1896

WordPress database error: [Table 'wp_posts' is marked as crashed and should be repaired]
SELECT SQL_CALC_FOUND_ROWS wp_posts.ID FROM wp_posts LEFT JOIN wp_term_relationships ON (wp_posts.ID = wp_term_relationships.object_id) WHERE 1=1 AND ( wp_term_relationships.term_taxonomy_id IN (1,54) ) AND wp_posts.post_type = 'post' AND (wp_posts.post_status = 'publish') GROUP BY wp_posts.ID ORDER BY wp_posts.post_date DESC LIMIT 0, 10