J&J, AbbVie Submit sNDA for Cancer Drug ImbruvicaBy
Janssen Biotech Inc., part of Johnson and Johnson, and AbbVie have submitted a supplemental new drug application (sNDA) for Imbruvica (ibrutinib) to the US Food and Drug Administration (FDA) for front-line use in patients with chronic lymphocytic leukemia (CLL). Imbruvica is being jointly developed and commercialized by Janssen and Pharmacyclics LLC, which AbbVie acquired in May 2015. Pharmacyclics is the investigational new drug (IND) holder for Imbruvica in the US and submitted the application to the FDA on behalf of the companies.
Imbruvica is now is indicated for the following: in patients with CLL who have received at least one prior therapy; in patients with CLL with 17p deletion; for treating WaldenstrÃ¶m's macroglobulinemia, a rare form of cancer; and for treating patients with mantle cell lymphoma who have received at least one prior therapy.
Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK). The BTK protein transmits important signals that tell B cells to mature and produce antibodies and is needed by specific cancer cells to multiply and spread. Imbruvica targets and blocks BTK, inhibiting cancer cell survival and spread, according to information from Johnson & Johnson.