UPDATE 1-Roche set to file armed antibody breast cancer drug

Posted: Published on March 31st, 2012

This post was added by Dr P. Richardson

* T-DM1 superior to Tykerb plus Xeloda in Phase III study

* Filing planned for Europe (Chicago Options: ^REURUSD - news) and U.S. this year

* T-DM1 delivers toxic payload with fewer side effects (Adds details on drug, reduced side effects)

ZURICH, March 30 (Reuters) - Roche said patients with an aggressive type of breast cancer lived longer after taking its experimental "armed antibody" drug without the disease worsening than those on a mix of GlaxoSmithKline (Other OTC: GLAXF.PK - news) drug Tykerb and Roche's Xeloda.

The positive results from the first Phase III trial of the medicine - dubbed T-DM1 - clears the way for it to be submitted to European and U.S. authorities for approval this year, boosting prospects for a key asset in the Swiss firm's pipeline.

Roche has been developing T-DM1 with ImmunoGen (NasdaqGM: IMGN - news) as a successor to its blockbuster Herceptin, which is expected to generate sales of around $6 billion this year.

A key advantage of T-DM1 over Herceptin is the fact that it causes fewer adverse side effects like hair loss and low white blood cell counts.

It combines trastuzumab, an antibody and the active ingredient in Herceptin, with the agent DM1 - a derivative of an extremely powerful type of chemotherapy called maytansine - which is carried directly into cells.

As well as having fewer unpleasant side effects, Roche believes its new drug also offers greater convenience, since it is one drug and eliminates the need to administer chemotherapy.

Analyst hopes for T-DM1 have been running high, following earlier good results in Phase II tests, and a filing of the product with regulators this year had been widely expected on the back of data from the so-called EMILIA clinical trial.

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UPDATE 1-Roche set to file armed antibody breast cancer drug

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