Pharmacyclics Inc. received encouraging news when the U.S. Food and Drug Administration (FDA) approved its oncology drug Imbruvica (ibrutinib).The U.S. regulatory body cleared the drug as a monotherapy for treating patients suffering from mantle cell lymphoma (MCL). The patients were treated at least once previously for the disease. Pharmacyclics has co-developed the drug with Janssen Biotech, a Johnson & Johnson (JNJ - Free Report) company.
The FDA decision marks the first approval for Pharmacyclics. Investors reacted positively to the news. We note that the FDA reviewed Pharmacyclics’ new drug application seeking marketing approval for Imbruvica for the indication on a priority basis. The NDA was submitted to the FDA in Jun 2013.
The FDA had granted breakthrough therapy designation to the drug for the indication earlier in the year. Pharmacyclics stated in its press release that Imbruvica is one of the first drugs to gain approval from the U.S. regulatory body via the breakthrough therapy designation route. Pharmacyclics is also seeking U.S. approval of the drug for previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
The FDA cleared Imbruvica for the MCL indication on the basis of encouraging data pertaining to overall response rate from a multi-center, international, single-arm study (n=111). The drug is recommended to be taken once daily (4 pills 140 mg each). The drug will cost $10,900 a month. Imbruvica will compete with drugs like Celgene Corporation’s (CELG - Free Report) Revlimid in the MCL market.
Successful commercialization of Imbruvica in the MCL indication would bring in substantial revenues to Pharmacyclics. The drug is being developed to treat other cancer forms as well.
Pharmacyclics, a biopharmaceutical company, carries a Zacks Rank #2 (Buy). Actelion Ltd. appears to be more attractive in the biopharma space with a Zacks Rank #1 (Strong Buy).