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9 results
9:53 AM, Aug 20, 2018  |  BC Extra | Company News

China approves Roche’s Alecensa for NSCLC

Roche (SIX:ROG; OTCQX:RHHBY) said China’s State Drug Administration approved Alecensa alectinib as monotherapy to treat anaplastic …
drug for the indication in November and December, respectively. The company said it will launch Alecensa
later this year, but declined to comment on pricing. Alecensa is one of 48 internationally-approved drugs …
2:58 PM, May 26, 2017  |  BC Extra | Company News

FDA expands Zykadia's label to first-line NSCLC

73% vs. 27% for chemotherapy. In April, Roche (SIX:ROG; OTCQX:RHHBY) said its own ALK inhibitor, Alecensa
alectinib, significantly improved PFS vs. Xalkori in the Phase III ALEX trial to treat ALK-positive NSCLC …
12:18 PM, Apr 10, 2017  |  BC Extra | Clinical News

Roche's Alecensa tops Xalkori in confirmatory NSCLC trial

Roche (SIX:ROG; OTCQX:RHHBY) said Alecensa alectinib significantly improved progression-free survival (PFS) vs. Xalkori crizotinib, meeting the …
to present full data from the 303-patient study at an upcoming medical meeting. Last week, Alecensa
improving PFS in the Phase III ALUR trial to treat ALK-positive NSCLC. The study compared Alecensa
2:28 PM, Apr 03, 2017  |  BC Extra | Clinical News

Roche's Alecensa passes Phase III NSCLC test

Roche (SIX:ROG; OTCQX:RHHBY) said Alecensa alectinib met the primary endpoint in the Phase III ALUR trial …
to treat anaplastic lymphoma kinase-positive non-small cell lung cancer. Alecensa significantly improved progression-free survival (PFS) vs …
of both platinum-based chemotherapy and Xalkori crizotinib. The open-label study compared twice-daily 600 mg oral Alecensa
3:25 PM, Dec 16, 2016  |  BC Extra | Company News

Celltrion biosimilar among CHMP recommendations

CEO David Ricks (see BioCentury, Oct. 24) . The committee recommended conditional approval of Roche's Alecensa
alectinib to treat anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer in patients previously treated …
12:00 AM, Dec 11, 2015  |  BC Extra | Top Story

Roche's Alecensa gets FDA nod for NSCLC

FDA granted accelerated approval to Alecensa alectinib from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY …
of the ALK inhibitor's March 4, 2016, PDUFA date. Genentech said it expects to launch Alecensa
4:41 PM, Jul 07, 2014  |  BC Extra | Top Story

Japan approves drugs for cancer, HCV, TB

Deltyba, a nitro-dihydro-imidazooxazole derivative, has conditional approval in the EU for pulmonary MDR-TB. MHLW approved alectinib
RO5424802 / CH5424802 ) from Roche (SIX:ROG; OTCQX:RHHBY) to treat anaplastic lymphoma kinase (ALK)-positive NSCLC …
5:31 PM, Oct 08, 2013  |  BC Extra | Company News

Chugai submits Japanese NDA for alectinib

Ltd. (Tokyo:4519) submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for alectinib
RO5424802 / CH5424802 ) to treat anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC …
5:53 PM, Sep 23, 2013  |  BC Extra | Company News

Breakthrough designation for Roche's alectinib

Roche (SIX:ROG; OTCQX:RHHBY) said FDA granted breakthrough therapy designation for alectinib (RO5424802/ CH5424802 ) to treat …