Takeda gets return on Ariad buy with approval of brigatinib

Takeda is already seeing a return on its $5.2 billion swoop for cancer drugs biotech Ariad at the beginning of the year after the FDA approved potential blockbuster brigatinib in lung cancer.

The FDA approved the drug, which will have the brand name Alunbrig, for patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer, who have progressed on or are intolerant to Pfizer’s Xalkori (crizotinib).

When Takeda bought Ariad at the beginning of the year, CEO Christophe Weber said Alunbrig has the potential to generate peak annual sales in excess of $1 billion.

In this indication Alunbrig will compete against Roche’s Alecensa and Novartis’ Zykadia – but Takeda’s biggest hope is a phase 3 trial comparing Alunbrig with Xalkori in previously untreated patients.

Takeda is bracing for the expiry this year of the US patent on its multiple myeloma drug Velcade, which has sales in excess of $2 billion, and hopes Alunbrig and other drugs picked up from Ariad will replace the lost revenues.

The company is hoping the drug will appeal to clinicians because of its performance against brain metastases in the second line indication.

Ross Camidge, director of thoracic oncology at the University of Colorado, said: “In recent years, small molecule ALK inhibitors have revolutionised the treatment options for those with advanced ALK+ non-small cell lung cancer. Nevertheless, there is still a need for additional ALK inhibitors like brigatinib (Alunbrig), which have a manageable safety profile and may address mechanisms of clinical resistance to crizotinib, including progression in the central nervous system.”

The central nervous system is a frequent site for metastases in this form of lung cancer, occurring in up to 70% of patients with ALK+ NSCLC who have been treated with a first-line ALK inhibitor.

As this is an accelerated approval based on phase 2 data from the ALTA trial, the FDA will require confirmatory data to allow Alunbrig  to remain on the market in the longer term.