Pharmatimes has reported on new cancer drugs this month:
European regulators have recommended conditional approval of GlaxoSmithKline’s new breast cancer drug Tyverb (lapatinib). The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a revised positive opinion after being asked by regulators to look at the drug again after clinical data suggested it could raise liver enzyme levels. Meanwhile GSK has won approval in Sweden for its 5 alpha-reductase inhibitor Avodart in combination with tamsulosin for the treatment of patients with moderate-to-severe benign prostatic hyperplasia symptoms.
Celgene’s Thalidomide Pharmion (thalidomide) has been granted full marketing authorisation by the EMEA for use in collaboration with melphalan and prednisone as a treatment for patients with newly diagnosed multiple myeloma the second most commonly-diagnosed blood cancer. No manufacturer or distributor apart from Celgene may now supply thalidomide in any form across the EU.