Specialty Pharma Journal Specialty, Precision & Technology
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint …
Tag Archives: PD-1
October, 2018
June, 2018
-
15 June
Apexigen and Yale Cancer Center Collaborate to Evaluate APX005M, Cabiralizumab, and Opdivo in Patients whose Disease has Progressed on Anti-PD-1/PD-L1 Therapy
San Carlos, CA, and New Haven, CT – June 14, 2018 – Apexigen, Inc., and Yale Cancer Center today announced a clinical trial collaboration to evaluate Apexigen’s APX005M in combination with cabiralizumab and Opdivo in patients with advanced solid tumors. The Phase 1/2 clinical trial will evaluate the safety, tolerability, and preliminary activity of …
-
14 June
Merck’s Keytruda Receives FDA Approval for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma
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®, the company’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed …
-
13 June
FDA Approves Merck’s Keytruda for Advanced Cervical Cancer Whose Tumors Express PD-L1
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®, the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors …
-
5 June
Merck’s Keytruda Shows Promise in Mid-Stage Study in Patients with Advanced Small Cell Lung Cancer
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced interim data from a cohort of the Phase 2 KEYNOTE-158 study evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in patients with previously treated advanced small cell lung cancer (SCLC). Findings showed an overall response …
May, 2018
-
31 May
Syndax and Nektar Therapeutics Partner for Immuno-Oncology Clinical Trial
WALTHAM, Mass. and SAN FRANCISCO, May 30, 2018 /PRNewswire/ — Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, and Nektar Therapeutics (Nasdaq: NKTR) today announced a non-exclusive, clinical collaboration to evaluate the safety and efficacy of Nektar’s NKTR-214, a CD122-biased agonist, …
-
24 May
Merck’s Keytruda Significantly Improved Overall Survival and Progression-Free Survival in Late-Stage NSCLC Study
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-407 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel, as first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC), met the dual primary endpoints …
-
9 May
OncoSec and Merck Expand Partnership to Evaluate Combination of ImmunoPulse IL-12 and Keytruda for Triple Negative Breast Cancer
SAN DIEGO, May 8, 2018 /PRNewswire/ — OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, has entered a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) to evaluate the combination of OncoSec’s ImmunoPulse® IL-12 with Merck’s anti-PD-1 …
-
1 May
Merck’s Keytruda Granted Priority Review by the FDA for First-Line Treatment of Metastatic Nonsquamous 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 accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA®, the company’s anti-PD-1 therapy, based on results of the Phase 3 KEYNOTE-189 trial. The application …
April, 2018
-
16 April
Keytruda-Pemetrexed-Platinum Chemotherapy Combination Significantly Improved Overall Survival in Late-Stage NSCLC Study
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from KEYNOTE-189, a pivotal Phase 3 trial evaluating KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and cisplatin or carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). …