Just two months after completing its deal to buy the Boston biotech Ariad, Takeda is getting a quick and important lift. On Friday, the FDA approved Alunbrig, an Ariad-developed med and potential blockbuster, as a second-line treatment for ALK-positive, non-small cell lung cancer.
An orphan drug approved under the FDA’s accelerated pathway, Alunbrig will be available for patients who've failed on treatment with Pfizer and Merck KGaA’s Xalkori.
Takeda execs have high hopes for the therapy, one of the key assets in its $5.2 billion Ariad buy. When Takeda closed the deal back in February, CEO Christophe Weber said his company believes the drug “will become a best-in-class ALK inhibitor ... with the potential to achieve peak annual sales of over $1 billion.”
Takeda’s oncology president Christophe Bianchi added that the med “has the potential to broaden our solid tumor franchise globally.” The drug is also under consideration for approval in Europe.
Speaking with FiercePharma Friday, Takeda’s David Kerstein, senior medical director and global clinical lead for Alunbrig, said the drugmaker plans to roll out the drug “as soon as possible” and will announce pricing then.
As a second-line ALK drug, Alunbrig will go up against Roche’s Alecensa and Novartis’ Zykadia. Kerstein said Takeda is “encouraged” by the supporting trial data, particularly Alunbrig's long duration of response and high activity against brain metastases, a “high burden area” in ALK+ NSCLC.
“To see the progress over a relatively short time has been really quite amazing,” Kerstein said. “We’re excited to be able to bring another treatment option for patients.”
In a phase 3 trial, Takeda is pitting the drug against Xalkori in previously untreated patients. The company believes that’s an “optimal setting” where Alunbrig can most benefit patients, Kerstein said. If that study comes up positive and the drugmaker wins a first-line approval, that would considerably expand the number of patients eligible for treatment.
The new approval comes at a critical time for Takeda, as the drugmaker preps for a patent loss on its multiple myeloma blockbuster Velcade later this year. Well aware of that impending sales slide, the company reportedly set aside $15 billion last September for a deal hunt, and signed off on the Ariad accord back in January.
The company has also nixed some drug development partnerships and entered new collaborations, including a rare disease tie-up with Harrington Discovery Institute inked on Thursday. To integrate the Ariad buy, Takeda is prepping a round of layoffs, according to the Boston Business Journal.
Takeda’s deal for Ariad also included Iclusig, a leukemia drug that’s been in the Congressional hot seat for price hikes. Analysts have predicted that med could hit $500 million in peak sales.