NSCLC – media

KEYTRUDA® (pembrolizumab) Monotherapy Met Primary Endpoint in Phase 3 KEYNOTE-042 Study, Significantly Improving OS as First-Line Therapy in Locally Advanced or Metastatic NSCLC Patients Expressing PD-L1 in at Least 1 Percent of Tumor Cells

Based on the recommendation of the DMC, the trial will continue to evaluate progression-free survival (PFS), which is a secondary endpoint. Results from KEYNOTE-042 will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.
- Source: finance.yahoo
- 690
- April 10, 2018
Clinical Trials keytruda Merck NSCLC
Phase III IMpower131 Study Showed Genentechs TECENTRIQ (Atezolizumab) Plus Chemotherapy (Carboplatin and ABRAXANE) Reduced the Risk of Disease Worsening or Death in the Initial Treatment of People with a Type of Advanced Squamous Lung Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ® (atezolizumab) plus chemotherapy (carboplatin and ABRAXANE® [albumin-bound paclitaxel; nab-paclitaxel]) reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in the initial (first-line) treatment of people with advanced squamous non-small cell lung cancer (NSCLC). Safety for the TECENTRIQ and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. At this interim analysis a statistically significant overall survival (OS) benefit was not observed and the study will continue as planned. These data will be presented at an upcoming oncology congress.
- Source: cleveland19
- 746
- March 22, 2018
Chemotherapy Clinical Trials Genentech NSCLC oncology
BMS’ Opdivo and Yervoy combo better than chemo in halting lung cancer progression

Bristol-Myers Squibb has revealed promising data from its ongoing Phase 3 study investigating the efficacy of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) compared to chemotherapy in the first-line treatment of advanced non-small-cell lung cancer (NSCLC) in patients whose cancers have a high tumour mutation burden (TMB), regardless of PD-L1 expression.
- Source: pharmafile
- 559
- February 7, 2018
BMS Chemotherapy NSCLC Opdivo TMB Yervoy
Afatinib Approval Expanded for Rare Lung Cancer Treatment

Boehringer Ingelheim announced the approval of a new indication for afatinib (Gilotrif), as the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (NDA) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
- Source: Raredr
- 715
- January 17, 2018
afatinib DNA FDA New Approvals NSCLC
EU OKs first-line use of Roche’s lung cancer drug Alecensa

Roche’s Alecesna has been cleared for use in Europe as a first-line treatment for ALK-positive non-small cell lung cancer (NSCLC), offering a new option for patients newly diagnosed with the disease.
- Source: Pharmatimes
- 482
- December 22, 2017
Alecesna New Approvals NSCLC
US FDA Accepts Regulatory Submission for TAGRISSO (Osimertinib) in 1st-Line EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of TAGRISSO® (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations). The FDA has granted TAGRISSO Priority Review status, and previously granted Breakthrough Therapy Designation for TAGRISSO in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.
- Source: finance.yahoo
- 619
- December 19, 2017
AstraZeneca CNS FDA New Approvals NSCLC TAGRISSO®
Boehringer Ingelheim initiates real-world study of treatment sequencing in EGFR mutation-positive lung cancer

Boehringer Ingelheim has initiated GioTag, a real-world study to assess the impact of sequential therapy in patients with EGFR mutation-positive (M+) advanced non-small cell lung cancer (NSCLC). Data from approximately 190 patients who received tyrosine kinase inhibitors (TKI) – afatinib* in first-line, followed by second-line osimertinib**as part of standard clinical practice – will be analysed to determine total time on treatment.
- Source: boehringer-ingelheim
- 521
- December 14, 2017
EGFR NSCLC Researches
FDA Approves Genentech’s Alecensa Lung Cancer Treatment

Genentech, a member of the Roche Group, 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 (NSCLC) as detected by an FDA-approved test.
- Source: Pharmpro
- 612
- November 9, 2017
ALK FDA New Approvals NSCLC sNDA
FDA Grants Priority Review To Gilotrif For Uncommon EGFR Mutations In Advanced NSCLC

Boehringer Ingelheim announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X or S768I substitution mutations as detected by an FDA-approved test.
- Source: careers.biospace
- 554
- October 13, 2017
EGFR New Approvals NSCLC sNDA
AstraZeneca’s Tagrisso Gets Breakthrough Therapy Designation

AstraZeneca announced that the FDA has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
- Source: finance.yahoo
- 586
- October 10, 2017
Company Insight EGFR FDA New Approvals NSCLC

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