T-DM1 show overall survival advantage as Roche/Genentech make US and EU filings
This article was originally published in Scrip
Executive Summary
Roche and its cancer specialist unit Genentech have announced that following the demonstration of an overall survival benefit in the Phase III EMILIA study, they will file for US and EU regulatory approval of the antibody-drug conjugate T-DM1 (trastuzumab emtansine). The filing had been widely expected since the antibody-drug conjugate – developed with cytotoxic and conjugation technology developed by Waltham, Massachusetts-based Immunogen - generated impressive progression-free survival results in EMILIA. Analysts are anticipating approval as early as the first quarter of 2013.
You may also be interested in...
Finance Watch: Pfizer Adds $3.5bn To Cash Stockpile, Reduces Stake In Haleon
Public Company Edition: Pfizer’s stake in Haleon dropped from 32% to 22.6% with a massive sale of shares of the GSK consumer health spinout. Also, Galderma prices its Swiss IPO, Madrigal grosses $600m in a post-approval offering and bluebird secured up to $175m in debt.
Finance Watch: Another Bevy Of VC Mega-Rounds, Including $175m For Capstan
Private Company Edition: Capstan and Engrail raised $175m and $157m, respectively, in series B venture capital rounds in addition to Madrigal’s $400m-plus launch and Clasp’s $150m series A.
Roche/Chugai’s Enspryng Not Good Enough In Phase III Myasthenia Gravis Study
Many companies have late-stage myasthenia gravis programs in Phase III, but argenx and its Vyvgart competitors won a reprieve with the failure of IL-6 inhibitor Enspryng (satralizumab).