The FDA has granted an accelerated approval for a supplemental indication for Iclusig (ponatinib). It is now approved to treat adult patients who have been newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). Iclusig is indicated to be used in combination with chemotherapy.
In November, Takeda said its blood cancer drug Iclusig topped Novartis’ Gleevec in a phase 3 trial in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL).
Five years after shelling out more than $5 billion for Ariad Pharmaceuticals and its rare leukemia drug Iclusig, Takeda is setting plans in motion for a potential label expansion into the first-line setting — but for now, the pharma giant is keeping its cards close.
Back in 2017, Takeda shelled out more than $5 billion for a smaller company called Ariad Pharmaceuticals, its leukemia drug Iclusig (ponatinib) and its ALK-inhibiting lung cancer drug Alunbrig (brigatinib).
Fast forward five years, and while Iclusig continues to pull in more than $200 million per year for Takeda, the company is now looking to fend off generic competitors, filing suit in New Jersey federal court earlier this week to block a competitor, Canada-based Apotex.
About one-third of chronic myeloid leukemia (CML) patients don’t survive past the five-year mark, in part thanks to built-up resistance to treatment options. And that’s a stat Takeda’s trying to change.
The drugmaker Monday unveiled data showing that among patients who had already tried two or more prior tyrosine kinase inhibitors prior to receiving its Iclusig, more than 50% of those who started on a 45 mg daily dose of the drug and scaled down to a 15 mg daily dose were still alive and hadn’t seen their disease worsen after five years.
Researchers with the Francis Crick Institute- and The Institute of Cancer Research recently published research suggesting that a new class of drugs that is helpful in treating breast cancers could help treat some of the hardest-to-treat lung cancers. They published their work in the journal Cell Reports.