Tag Archives: TKI

April, 2018

5 April
FDA Grants Priority Review to Pfizer’s Dacomitinib for Treatment of Metastatic NSCLC

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted priority review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), for the first-line treatment of patients with locally advanced or metastatic non-small cell …
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31 January
Seattle Genetics to Acquire Cascadian Therapeutics for $614 Million, Adding Late-Stage Breast Cancer Program

att BOTHELL, Wash. & SEATTLE–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) and Cascadian Therapeutics, Inc. (Nasdaq:CASC) today announced the signing of a definitive merger agreement under which Seattle Genetics has agreed to acquire Cascadian Therapeutics. Under the terms of the agreement, Seattle Genetics will pay $10.00 per share in cash, or approximately $614 …
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18 July
FDA Approves Puma’s Nerlynx for Early Stage HER2-Positive Breast Cancer

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (Nasdaq: PBYI) today announced that the U.S. Food and Drug Administration (FDA) has approved NERLYNX™ (neratinib), formerly known as PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. Puma expects neratinib …
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18 July
AstraZeneca’s Tagrisso Meets Main Goal in Late-Stage Lung Cancer Study

18 July 2016 — AstraZeneca today announced that the Phase III AURA3 trial met its primary endpoint, demonstrating superior progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The AURA3 randomised trial assessed the efficacy and safety of Tagrisso as a 2nd-line treatment in more than 400 patients with EGFR T790M …
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8 July
Pfizer’s Sutent Meets Primary Endpoint in its Late-Stage Kidney Cancer Trial

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the S-TRAC clinical trial (Sunitinib Trial in Adjuvant Renal Cancer), a Phase 3 study of SUTENT versus placebo in the adjuvant setting, met its primary endpoint of improving disease-free survival (DFS) as determined by blinded independent central review in patients with renal cell …
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16 May
FDA Expands Approval of Eisai’s Lenvima in Kidney Cancer

WOODCLIFF LAKE, N.J., May 13, 2016 /PRNewswire/ — Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) approved LENVIMA® (lenvatinib), the company’s multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an …
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15 April
Plasma Genotyping to Predict Treatment Benefit in Patients with NSCLC

GENEVA, Switzerland, 15 April 2016 – The benefit of plasma genotyping to predict treatment benefit in patients with non-small-cell lung cancer (NSCLC) is confirmed in three studies presented today at the European Lung Cancer Conference (ELCC) 2016 in Geneva, Switzerland.1 Researchers however warned that plasma tests are unlikely to fully …
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21 December
Boehringer Ingelheim’s NSCLC Candidate Receives FDA Breakthrough Therapy Designation

RIDGEFIELD, Conn., Dec. 21, 2015 /PRNewswire/ — Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its investigational third-generation epidermal growth factor receptor (EGFR) mutant-specific tyrosine kinase inhibitor (TKI), BI 1482694 (HM61713). The designation is based on results from the Phase …
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