- The FDA has approved Imbruvica for first line treatment of chronic lymphocytic leukemia (CLL), a blood cancer which primarily affects the elderly, co-developer Janssen said on Friday.
- Developed jointly by Janssen and AbbVie, Imbruvica has previously received FDA approval for second line treatment of CLL, and for a small subset of CLL patients with a specific genetic mutation. The new indication is for treatment naive patients.
- The FDA approval gives the drug a major boost, just days after the UK's cost regulatory rejected the drug for its $78,000 a year price tag.
The first line indication greatly broadens the population of patients who could be treated with Imbruvica. This is a major win for Abbvie . The Illinois-based company spent $21 billion last year to buy Pharmacyclics, one the original developers, and has blockbuster hopes for the drug.
Imbruvica won a green light from the FDA based on a randomized phase 3 trial comparing the drug to the chemotherapy agent chlorambucil. The study demonstrated a comparative 84% reduction in the risk of disease progression or death and improved overall response rates in patients treated with Imbruvica.
"This approval represents a significant leap forward for patients diagnosed with CLL who may want to consider an alternative first-line treatment to traditional chemotherapy," said Michael Severino, chief scientific officer at AbbVie.
In 2015, Imbruvica pulled in $754 million in global revenues for AbbVie, and $689 million for Janssen (Johnson & Johnson). Janssen earns the lion's share of international revenues based on a profit-sharing agreement with AbbVie.