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22 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
8:00 AM, Oct 06, 2017  |  BC Week In Review | Clinical News  |  Clinical Results

Roche reports detailed Phase III data for Alecensa in previously treated NSCLC

in 107 patients with non-small cell lung cancer (NSCLC) showing that twice-daily 600 mg oral Alecensa
alectinib (AF802, CH5424802, RG7853, RO5424802) led to a median progression-free survival (PFS) as assessed by investigators …
docetaxel (p …
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 …
10:05 PM, Jun 15, 2017  |  BC Week In Review | Clinical News  |  Clinical Results

Genentech reports detailed Phase III data for Alecensa as first-line treatment of NSCLC

advanced non-small cell lung cancer (NSCLC) showing that first-line treatment with twice-daily 600 mg oral Alecensa
alectinib (AF802, CH5424802, RG7853, RO5424802) significantly reduced the risk of disease progression or death by 53 …
survival (PFS) by investigator assessment, the primary endpoint, was not reached in patients who received Alecensa
5:34 PM, Apr 11, 2017  |  BC Week In Review | Clinical News  |  Clinical Results

Alecensa: Ph III ALEX data

Phase III ALEX trial in 303 treatment-naïve NSCLC patients showed that twice-daily 600 mg oral Alecensa
as first-line treatment met the primary endpoint of improving PFS vs. Xalkori crizotinib. Alecensa has accelerated …
Francisco, Calif.  Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan  Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland  Product: Alecensa
11:42 AM, Apr 07, 2017  |  BC Week In Review | Clinical News  |  Clinical Results

Alecensa: Ph III ALUR data

international Phase III ALUR trial in 119 NSCLC patients showed that twice-daily 600 mg oral Alecensa
crizotinib. This half, Roche expects to report data from the Phase III ALEX trial comparing Alecensa
a first-line treatment of ALK-positive NSCLC. Roche said ALEX would be the confirmatory trial for Alecensa's …
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

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