Pharmacyclics’ Imbruvica gains EU approval for two blood cancers

17 October 2014

US drugmaker Pharmacyclics (Nasdaq: PCYC) has received marketing approval from the European Commission for Imbruvica (ibrutinib) throughout the 28 member states of the European Union.

The company’s share rose 4.4% to $113.93 by mid-morning trading in the USA. Roth Capital boosts its price target on Pharmacyclics from $185 up to $188 and maintains a Buy rating on the stock following news if the EU approval for Imbruvica. Pharmacyclics also announced a deal with Roche to trial its drug with Gazyva (obinutuzumab; see separate story).

Imbruvica, a first-in-class, oral, once-daily, non-chemotherapy treatment, is now cleared to be marketed in Europe for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, or in first line CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemotherapy.

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