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Tyverb (lapatinib)

Region

🇪🇺 EU

Active substance

lapatinib

Company

Novartis Europharm Limited

Status

Authorised

Therapeutic area

Breast Neoplasms

EU approval

Tue 10 Jun 2008

Application

EMEA/H/C/000795

ATC

L01EH01

Official record

www.ema.europa.eu

Indication

Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting; in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy; in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.