FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson & Johnson (NYSE: JNJ) and Pharmacyclics' (Nasdaq: PCYC) Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL), a rare blood and bone marrow disease, patients who have received at least one previous therapy. Pharmacyclics shares rose 6.7% to $141.75 in afternoon trading.

Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. Last fall, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy (The Pharma Letter November 14, 2013). At that time, treatment cost with the drug was said to be $130,000 a year.

“Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA completed its review of Imbruvica’s new indication under the agency’s accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most,” he noted.

Peak sales of $6.5 billion forecast

RBC Capital Markets analyst Michael Yee expects Imbruvica to generate peak sales of $6.5 billion in 2026, including US sales of $3 billion. The drug was developed with J&J subsidiary Janssen Biotech under a 2011 agreement which involved $150 million upfront and further potential payments of $825 million to Pharmacyclics. The latest approval of the drug triggers a $60 million milestone payment to Pharmacyclics.