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Roche snags pair of FDA breakthrough designations

Accelerates approval process for NSCLC treatment Alecensa and immunotherapy Actemra
Roche

Roche's cancer drug Alecensa and immunotherapy Actemra have been awarded breakthrough designations (BTDs) by the US FDA, potentially speeding up approval of new indications.

In the case of Alecensa (alectinib), the breakthrough status is for the drug's use in the first-line treatment of people with ALK-positive non-small cell lung cancer (NSCLC) and based on the results of the J-ALEX trial.

Alecensa was given accelerated approval last year for use in ALK-positive NSCLC in patients who have previously been treated with Pfizer's Xalkori (crizotinib), also on the back of a BTD. It is one of three ALK inhibitors on the market alongside Xalkori and Novartis' Zykadia (ceritinib), which was also approved last year as a second-line therapy after Pfizer's drug.

In J-ALEX - conducted by Roche's Japanese subsidiary Chugai - Alecensa reduced the risk of disease-worsening or death by 66% compared to Xalkori. Approval for first-line use would increase the eligible patient population for Alecensa, and also extend the amount of time people receive the drug.

That should lend additional momentum to the product, which according to Roche chief executive Severin Schwann has got off to a "really terrific start" in the market with a market share approaching 60% in Japan, its first market. Sales reached CHF 72m ($74m) in the first six months of the year.

Meanwhile, Roche's interleukin-6 inhibitor RoActemra/Actemra (tocilizumab) picked up a BTD for giant cell arteritis, a chronic and potentially life-threatening autoimmune condition in which serious inflammation is seen in arteries.

The new status follows the announcement of positive data from the GiACTA trial earlier this year. In that study, Actemra, given in combination with corticosteroid therapy, was able to improve remission rates over 12 months compared to corticosteroids alone.

First launched in Japan for 2005 for Castleman's disease - and subsequently getting the green light for rheumatoid arthritis and systemic juvenile idiopathic arthritis in several markets including the US and EU - Actemra is the only IL-6 inhibitor on the market and has already passed the blockbuster sales threshold.

The drug is however facing its first competition in the form of GlaxoSmithKline and Johnson & Johnson's sirukumab, filed for rheumatoid arthritis last month.

In the first half of the year Actemra made CHF 814m in sales, a rise of 17%, and approval in giant cell arteritis - the most common form of systemic vasculitis in adults - could open up a sizeable new market for the drug.

With a rival now on its heels, Roche is also evaluating Actemra in other indications, including large vessel vasculitis and systemic sclerosis.

Article by
Phil Taylor

5th October 2016

From: Regulatory

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