With new FDA nod, Roche's Alecensa set to challenge Pfizer, Novartis in first-line lung cancer

Roche's lung cancer drug Alecensa had been relegated to patients who'd failed on treatment with one of its rivals, but a new FDA nod is changing all that. It's now approved to treat newly diagnosed patients with ALK-positive disease, and Roche has some Xalkori-beating data to back it up.

Xalkori, of course, was the first drug approved to target tumors that test positive for an ALK gene abnormality, which accounts for less than 5% of all cases of the disease. Alecensa was approved in 2015 to treat patients who had failed on Xalkori.

Now, Alecensa is cleared for previously untreated patients, a larger group, and it'll go head to head not only with Xalkori, but with Novartis' Zykadia, which won its own first-line nod earlier this year.

Xalkori remains the market leader, if not its growth star. It posted $442 million in nine-month sales worldwide, up 6% over the same period in 2016. Novartis doesn't break out Zykadia sales, meaning it's less important to that drugmaker's top line—and meaning that Xalkori is the drug to beat in the first-line market.

Roche has plans for that: In the phase 3 trial that supported Alecensa's new approval, Alex, the drug topped Xalkori at holding off cancer growth by a wide margin. Median progression-free survival was 25.7 months for Alecensa patients, compared with 10.4 months for those taking Xalkori. Compared with the Pfizer drug, Alecensa cut the risk of disease worsening or death by 47%, Roche said Tuesday.

Alecensa also bested Xalkori at preventing brain metastases, which are more common among ALK-positive patients because it’s "such an aggressive tumor," Dietmar Berger, Roche’s global head of clinical development in hematology and oncology, told FiercePharma at the American Society of Clinical Oncology meeting in June, where the Alex details were first presented. Patients in the Alecensa group recorded just a 9% incidence of brain metastases at the 12-month mark, while 41% of patients in the Xalkori arm developed them.

Overall, the data "are really clear in the sense that, in my view, this will become, or is, the new standard of care for first-line," Berger said at the time.

Alecensa has already posted big gains since its first approval. At 244 million Swiss francs, sales for the first nine months of 2017 were double those for the same period last year.

Takeda won approval for its own ALK-targeted cancer drug, Alunbrig, in April, soon after acquiring it in a $5.2 billion buyout of Ariad Pharmaceuticals. Alunbrig is currently only cleared to treat patients who've failed on another ALK drug.