Specialty Pharma Journal Specialty, Precision & Technology
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced …
Tag Archives: NSCLC
December, 2018
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14 December
Vargatef Plus Docetaxel Could be an Option After Failure of Immunotherapy in Lung Cancer
INGELHEIM, Germany–(BUSINESS WIRE)–Boehringer Ingelheim announced today the first interim results of VARGADO, an ongoing non-interventional study in routine clinical practice in Germany evaluating the efficacy and safety of Vargatef® (nintedanib) and docetaxel in patients with stage III/IV locally advanced or metastatic non-small cell lung cancer (NSCLC) of adenocarcinoma histology. The study …
November, 2018
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16 November
AstraZeneca Provides Update on the Phase 3 Trial of Imfinzi and tremelimumab in Stage IV Non-Small Cell Lung Cancer
AstraZeneca and MedImmune, its global biologics research and development arm, today announced final overall survival (OS) results for the Phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy and the combination of Imfinzi and tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) platinum-based chemotherapy in previously-untreated patients with Stage IV …
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9 November
New Data Support Ongoing Clinical Program for Lenvima and Keytruda Combination Across Multiple Tumor Types
TOKYO & KENILWORTH, N.J.–(BUSINESS WIRE)–Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from presentations of new data and analyses of LENVIMA® (lenvatinib), an orally available kinase inhibitor discovered by Eisai, in combination with Merck’s anti-PD-1 …
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8 November
Immunomedics Expands Clinical Collaboration With Astrazeneca to Include Metastatic Non-Small Cell Lung Cancer
MORRIS PLAINS, N.J., Nov. 07, 2018 (GLOBE NEWSWIRE) — Immunomedics, Inc., (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced its current clinical collaboration with AstraZeneca (NYSE: AZN) and MedImmune for the development of Imfinzi® (durvalumab) and sacituzumab govitecan combination therapy has been broadened to include second-line …
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5 November
FDA Approves Pfizer’s Lorbrena for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved LORBRENA® [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one …
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1 November
FDA Approves Merck’s Keytruda in Combination with Chemotherapy for First-Line Treatment of Metastatic Squamous NSCLC
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell …
October, 2018
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24 October
Genentech’s Tecentriq Plus Chemotherapy as Initial Treatment Helped Advanced Non-Squamous NSCLC Patients Live Significantly Longer than Chemotherapy Alone
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III IMpower130 study of Tecentriq® (atezolizumab) plus chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of people with previously untreated metastatic non-squamous non-small cell lung cancer …
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19 October
Takeda to Present Results from Phase 3 Trial Highlighting Intracranial Efficacy of Alunbrig Versus Crizotinib in First-Line Advanced ALK+ NSCLC
CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma …
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19 October
Study Shows using Giotrif/Gilotrif Followed by Osimertinib Provides a Median of 27.6 Months of Chemotherapy-Free Time in Patients with NSCLC
INGELHEIM, Germany–(BUSINESS WIRE)–Boehringer Ingelheim today announced results from GioTag, a real-world retrospective study which examined the impact of first-line Giotrif®/Gilotrif® (afatinib) followed by osimertinib, in epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC) patients with acquired T790M mutations, the most common mechanism of resistance to first- and …