France OKs Early Access To Tecentriq For SCLC Pending EU Approval
Tecentriq has become the second authorized medicine to be made available for an unapproved indication under modifications to France’s early access program. Patients with small cell lung cancer can now be given the product pending EU approval of its use in this condition.
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Roche's cancer drugs, Tecentriq (atezolizumab) and Kadcyla (trastuzumab emtansine), are the latest products to be granted French temporary use authorizations for new, as yet unapproved indications.
France’s medicines and medical devices regulator wants to build up its role in the EU regulatory system, make its inner workings more accessible to stakeholders and the outside world, and improve the way it deals with medicine shortages.
EU approval of Tecentriq and Avastin together with chemo for the first-line treatment of metastatic non-squamous NSCLC is a positive advance for Roche, but analysts say the combo has a long way to go still to catch up with Merck & Co’s Keytruda combination.