Tag Archives: Alecensa

October, 2018

10 October
Genentech to Present New Positive Data from its Broad Cancer Immunotherapy Program and Across a Wide Range of Cancers

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new results from a number of studies across its industry-leading oncology portfolio of approved and investigational medicines will be presented at the European Society for Medical Oncology (ESMO) 2018 Congress, taking …
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18 May
Genentech’s Alecensa Helped Patients with ALK-Positive Metastatic NSCLC Live Almost 3 Years Without Disease Worsening or Death

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced follow-up data from the Phase III ALEX study, showing that as an initial treatment Alecensa® (alectinib) significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 57 percent (hazard ratio …
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7 November
Genentech’s Alecensa Receives FDA Approval for Treatment of ALK-Positive Metastatic NSCLC

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer …
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6 September
Roche’s Alecensa Demonstrates Positive Results in Late-Stage Study in Patients with ALK-Positive Advanced NSCLC

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the global phase III ALUR study showing that Alecensa® significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), who …
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10 April
Genentech’s Alecensa Demonstrates Superiority to Crizotinib in Late-Stage NSCLC Study

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the global, randomized Phase III ALEX study met its primary endpoint and showed that Alecensa®(alectinib) as an initial (first-line) treatment significantly reduced the risk of disease worsening or death (progression-free survival, PFS) …
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5 October
Genentech’s Alecensa Receives Second Breakthrough Therapy Designation from the FDA

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it has received a second Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its anaplastic lymphoma kinase (ALK) inhibitor, Alecensa (alectinib). The latest BTD was granted for the treatment of …
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14 December
Roche’s Alecensa Receives FDA Approval for Treatment of ALK-Positive Lung Cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) granted accelerated approval to Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. In the pivotal …
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