Roche’s Alecensa wins EU panel’s nod against mutated lung cancer


ZURICH (Reuters) – Swiss drugmaker Roche’s Alecensa has been recommended for approval in Europe as a first-line treatment for mutated lung cancer, a key European Medicines Agency (ESA) experts panel said on Friday.

Alecensa is among new drugs Roche is counting on to help offset patent declines for its older medicines. Zuercher Kantonalbank analyst Michael Nawrath estimates annual sales of Alecensa will hit 1.4 billion Swiss francs ($1.43 billion) by 2024 and capture about 70 percent of the market.

The Committee for Medicinal Products for Human Use (CHMP) backed Alecensa for adults as an initial monotherapy against ALK positive non-small cell lung cancer.

The European Commission, which must issue final approval, usually follows the CHMP’s recommendations.

Patients taking the targeted lung cancer drug have a far lower risk of their disease spreading in the brain than those on Pfizer’s Xalkori, the current standard of care, according to clinical trial data.

Alecensa was previously approved to treat lung cancer in patients who had failed other treatments.

The race for new first-line treatments for ALK-positive lung cancer has grown crowded.

Novartis also has a relatively new drug called Zykadia, as does Takeda with its Alunbrig.

Roche is still awaiting first-line approval for Alecensa in the United States, where it won priority review from the Food and Drug Administration in August.

Among other hotly expected drug decisions this year, Roche is still awaiting European approval for its multiple sclerosis medicine Ocrevus, but the CHMP release on Friday did not mention that drug.

Ocrevus has already been approved in the United States and racked up 192 million francs in first-half sales, a factor behind Roche’s decision in July to upgrade its full-year sales growth forecast.


Reporting by John Miller; Editing by Keith Weir


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