GlaxoSmithKline says it has filed a new drug application in Japan for its breast cancer drug Tykerb, which gained approval in the USA last month.
The drugmaker is seeking the green light for Tykerb (lapatinib) as a monotherapy and in combination with Roche's chemotherapy agent Xeloda (capecitabine), for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress HER2 and who have received other therapies including Herceptin (trastuzumab). Marketing applications for the drug have also been filed in the European Union, Switzerland, Canada, Brazil, Australia and South Korea.
GSK has also announced the submission of a regulatory file to the European Medicines Agency (EMEA) under Article 58 for the combination vaccine candidate Globorix (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, Neisseria meningitides serogroups A and C).
In clinical trials including countries in Africa and Asia, the conjugate meningococcal vaccine has demonstrated a good safety profile and immunogenicity against meningococcal meningitis caused by Neisseria meningitidis serogroups A and C, the firm said, noting that under Article 58, the EMEA, in cooperation with the World Health Organisation, gives a scientific opinion on the efficacy, quality and safety of products intended for use exclusively outside the European Union.