Tag Archives: NSCLC

Roche on Tecentriq’s US FDA Priority Review grant: New treatment options are urgently needed in early-stage non-small cell lung cancer

Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme Based on results of the Phase III IMpower010 study, presented at ASCO, that showed adjuvant Tecentriq improved disease-free survival by more than one-third in PD-L1-positive early-stage lung cancer, compared with … Read the full press release

AstraZeneca’s Imfinzi (durvalumab) approved in the US for new four-week 1,500mg fixed-dosing option

(PRESS RELEASE) CAMBRIDGE, 20-Nov-2020 — /EuropaWire/ — AstraZeneca (LON: AZN), a global, science-led biopharmaceutical company, has announced the US Food and Drug Administration (FDA) approval of its Imfinzi (durvalumab) for an additional dosing option, a 1,500mg fixed dose every four … Read the full press release

AstraZeneca Phase III PACIFIC trial: Imfinzi demonstrated statistically-significant and clinically-meaningful improvement in PFS

Imfinzi improves progression-free survival (PFS) by more than 11 months compared to standard of care and is the first medicine to show superior PFS in this setting Data presented at the ESMO 2017 Congress follows FDA’s recent Breakthrough Therapy Designation … Read the full press release

GlaxoSmithKline plc received FDA Breakthrough Therapy designation for its Tafinlar® (dabrafenib)

Marks GSK’s fourth Breakthrough Therapy designation London, UK, 17-1-2014 — /EuropaWire/ —  GlaxoSmithKline plc (LSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Tafinlar®(dabrafenib) for treatment of patients with metastatic BRAF V600E … Read the full press release

Roche launches Elecsys ProGRP test that distinguishes the two main types of lung cancer

New test expands cancer diagnostics portfolio and strengthens Roche Diagnostics’ comprehensive tumour marker menu 19-7-2013 — /europawire.eu/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the global launch (except US) of Elecsys ProGRP, a test that distinguishes between the two … Read the full press release