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11 results
12:42 PM, Nov 10, 2017  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves Genentech's Alecensa for first-line NSCLC

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said FDA approved an sNDA for Alecensa alectinib
AF802, CH5424802, RG7853, RO5424802) as first-line treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung …
cancer (NSCLC). FDA also converted to full approval its accelerated approval of Alecensa to treat ALK-positive …
5:35 PM, Oct 19, 2017  |  BC Week In Review | Clinical News  |  Regulatory

CHMP recommends Roche's Alecensa for first-line NSCLC

EMA's CHMP recommended approval of Alecensa alectinib (AF802, CH5424802, RG7853, RO5424802) from the Genentech Inc. unit …
kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). The committee also recommended full approval of Alecensa
as a second-line therapy for ALK-positive NSCLC in patients who failed treatment with Xalkori crizotinib. Alecensa
4:07 PM, Aug 28, 2017  |  BC Week In Review | Clinical News  |  Regulatory

FDA accepts Alecensa sNDA for first-line NSCLC

Priority Review to an sNDA from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for Alecensa
alectinib (AF802, CH5424802, RG7853, RO5424802) as first-line treatment of anaplastic lymphoma kinase (ALK)-positive advanced or metastatic …
non-small cell lung cancer (NSCLC). Its PDUFA date is Nov. 30. Alecensa has accelerated approval in …
6:06 PM, Feb 21, 2017  |  BC Week In Review | Clinical News  |  Regulatory

Alecensa regulatory update

The European Commission granted conditional approval to Alecensa alectinib from Roche to treat anaplastic lymphoma kinase …
compound elsewhere. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan  Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland  Product: Alecensa
4:41 PM, Dec 20, 2016  |  BC Week In Review | Clinical News  |  Regulatory

Alecensa regulatory update

EMA’s CHMP recommended conditional approval of Alecensa alectinib from Roche to treat anaplastic lymphoma kinase (ALK)-positive …
compound elsewhere. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan  Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland  Product: Alecensa
12:00 AM, Oct 10, 2016  |  BC Week In Review | Clinical News  |  Regulatory

Alecensa alectinib regulatory update

FDA granted breakthrough therapy designation to Alecensa alectinib from Roche to treat anaplastic lymphoma kinase (ALK)-positive …
Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan   Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland   Product: Alecensa
12:00 AM, Dec 21, 2015  |  BC Week In Review | Clinical News  |  Regulatory

Alecensa alectinib regulatory update

FDA granted accelerated approval to Alecensa alectinib from the Genentech unit of Roche to treat anaplastic …
see BioCentury, May 25). Roche is conducting the open-label, international Phase III ALEX trial comparing Alecensa
Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan   Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland   Product: Alecensa
12:00 AM, Sep 14, 2015  |  BC Week In Review | Clinical News  |  Regulatory

Alecensa alectinib regulatory update

FDA accepted and granted Priority Review to an NDA from Roche’s Genentech unit for alectinib to …
which is majority owned by Roche, discovered the compound and markets it in Japan as Alecensa
Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan   Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland   Product: Alecensa
12:00 AM, Jul 14, 2014  |  BC Week In Review | Clinical News  |  Regulatory

Alecensa alectinib regulatory update

Japan’s Ministry of Health, Labor and Welfare (MHLW) approved an NDA from Chugai for Alecensa alectinib
the compound and is developing it in Japan. Roche has rights to the compound elsewhere. Alecensa
Pharmaceutical Co. Ltd . (Tokyo:4519), Tokyo, Japan   Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland   Product: Alecensa
12:00 AM, Oct 14, 2013  |  BC Week In Review | Clinical News  |  Regulatory

Alectinib regulatory update

Chugai submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for alectinib to …
unresectable, recurrent or advanced anaplastic lymphoma kinase (ALK) fusion gene-positive non-small cell lung cancer (NSCLC). Alectinib
Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan   Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland   Product: Alectinib

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