Breakthrough therapy

ENHERTU® Approved in Japan for the Treatment of Patients with HER2 Positive Metastatic Gastric Cancer

Retrieved on: 
Friday, September 25, 2020
Oncology, Health, Genetics, Other Health, General Health, Clinical trials, Pharmaceutical, Clinical medicine, Health, Drugs, Antineoplastic drugs, Breakthrough therapy, RTT, Immunology, Cancer treatments, Trastuzumab deruxtecan, Trastuzumab, HER2/neu, Breast cancer, Gastric Cancer, DESTINY-Gastric01, ENHERTU, the Clinical Development Program, the Collaboration between Daiichi Sankyo and AstraZeneca, Daiichi Sankyo Cancer Enterprise, Daiichi Sankyo

Efficacy and safety of ENHERTU in patients with HER2 positive unresectable advanced or recurrent gastric cancer without a prior trastuzumab-containing regimen has not been established.

Key Points: 
  • Efficacy and safety of ENHERTU in patients with HER2 positive unresectable advanced or recurrent gastric cancer without a prior trastuzumab-containing regimen has not been established.
  • Drug related adverse reactions occurred in 122 patients (97.6%) of the 125 patients (including 99 Japanese patients) who received ENHERTU.
  • In addition to approval in Japan for the treatment of patients with HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy, ENHERTU (5.4 mg/kg) is also approved in Japan and the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting based on the DESTINY-Breast01 trial.
  • In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients.

Genetron Health and CStone Pharmaceuticals Announce Launch of Clinical Trial in China for Companion Diagnostic Test in Development for Avapritinib

Retrieved on: 
Friday, September 25, 2020
Health, Clinical medicine, Medicine, Cancer treatments, Avapritinib, Breakthrough therapy, Tyrosine kinase receptors, Gastrointestinal stromal tumor, PDGFRA, Brachyury, Gist, National Medical Products Administration

The test has been validated by the testing center of the National Medical Products Administration (NMPA) and is now being used inthis multi-center clinical trial in China.

Key Points: 
  • The test has been validated by the testing center of the National Medical Products Administration (NMPA) and is now being used inthis multi-center clinical trial in China.
  • CStone submitted New Drug Applications for avapritinib in PDGFRA exon 18 mutant gastrointestinal stromal tumors (GIST) to regulatory agencies in Taiwan and Mainland China in March and April 2020, respectively.
  • Preliminary results demonstrated the robust clinical activity of avapritinib in Chinese patients with GIST harboring the PDGFRA D842V mutation.
  • Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization.

Kiniksa Announces Rilonacept Analyst Day Now Tuesday, September 29th

Retrieved on: 
Thursday, September 24, 2020
Medical specialties, Clinical medicine, RTT, Immunosuppressants, Rilonacept, Health, Pericarditis, Breakthrough therapy

The event will feature presentations from the Kiniksa management team on the market opportunity for rilonacept in recurrent pericarditis as well as the companys continued commercial preparations and launch strategy.

Key Points: 
  • The event will feature presentations from the Kiniksa management team on the market opportunity for rilonacept in recurrent pericarditis as well as the companys continued commercial preparations and launch strategy.
  • Kiniksa will host a webcast and conference call at 8:00 a.m. Eastern Daylight Time on Tuesday, September 29th, 2020.
  • The presentation will be accessible through this link as well as through the Investors & Media section of the company's website .
  • The FDA granted Breakthrough Therapy designation to rilonacept for recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for pericarditis in 2020.

Opdivo (nivolumab) Significantly Improves Disease Free-Survival vs. Placebo as Adjuvant Therapy for Patients with High-Risk, Muscle-Invasive Urothelial Carcinoma in Phase 3 CheckMate -274 Trial

Retrieved on: 
Thursday, September 24, 2020
FDA, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Clinical medicine, Drugs, Medicine, RTT, Bristol-Myers Squibb, Breakthrough therapy, Antineoplastic drugs, Nivolumab, Ipilimumab, Pneumonitis, Renal cell carcinoma, Melanoma

Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

Key Points: 
  • Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
  • OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
  • In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients.
  • In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 10% (5/49) of patients.

Capricor Therapeutics to Present Results from the HOPE-2 Trial with CAP-1002 in Duchenne Muscular Dystrophy at the International World Muscle Society Virtual Congress 2020

Retrieved on: 
Wednesday, September 23, 2020
Muscular dystrophy, Breakthrough therapy, Orphan drugs, RTT

We continue to discuss this program with the FDA to determine next steps and a pathway forward towards potential approval.

Key Points: 
  • We continue to discuss this program with the FDA to determine next steps and a pathway forward towards potential approval.
  • We are proud to present this data at a prestigious industry event like WMS 2020 to further raise awareness of this debilitating disease."
  • In May 2020, Capricor announced positive topline 12-month results of the HOPE-2 clinical trial using CAP-1002 to treat patients in advanced stages of DMD.
  • The International Virtual Congress of the World Muscle Society will take place from September 28 through October 2, 2020.

Genmab Commences Binding Arbitration of Two Matters Under License Agreement with Janssen

Retrieved on: 
Tuesday, September 22, 2020
Drugs, Health care, Health, Genmab, Orphan drugs, Breakthrough therapy, Daratumumab, Johnson & Johnson, Arbitration, Janssen Biotech, Janssen

Copenhagen, Denmark; September 22, 2020 Genmab A/S (Nasdaq: GMAB) announced today that it has commenced binding arbitration of two matters arising under its license agreement with Janssen Biotech, Inc. (Janssen) relating to daratumumab.

Key Points: 
  • Copenhagen, Denmark; September 22, 2020 Genmab A/S (Nasdaq: GMAB) announced today that it has commenced binding arbitration of two matters arising under its license agreement with Janssen Biotech, Inc. (Janssen) relating to daratumumab.
  • Under the license agreement, Genmab is, among other things, entitled to royalties from Janssen on sales of daratumumab (marketed as DARZALEX for intravenous administration and, in the United States, as DARZALEX FASPRO for subcutaneous administration).
  • While Genmab intends to vigorously protect its rights under the agreement, the outcome of any arbitration proceeding, as well as its duration, is inherently uncertain.
  • Based on currently available information, Genmab does not expect these matters to materially affect its 2020 financial guidance.

ALX Oncology to Collaborate with Merck on Phase 2 Immuno-Oncology Studies Evaluating ALX148, Targeting CD47, in Combination with KEYTRUDA® (pembrolizumab) in Patients with Head & Neck Cancer

Retrieved on: 
Tuesday, September 22, 2020
Cancer treatments, Clinical medicine, Drugs, Antineoplastic drugs, Breakthrough therapy, Cancer immunotherapy, Pembrolizumab, RTT, Merck & Co., Head and neck cancer, Merck

Under the terms of the agreement, ALX Oncology will conduct a Phase 2 program comprising two separate Phase 2 studies.

Key Points: 
  • Under the terms of the agreement, ALX Oncology will conduct a Phase 2 program comprising two separate Phase 2 studies.
  • The second study will evaluate ALX148 in combination with KEYTRUDA and standard chemotherapy for the first line treatment of patients with metastatic or unresectable, recurrent HNSCC.
  • This collaboration builds upon the compelling combination activity observed in patients with ALX148 and KEYTRUDA, said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology.
  • KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121)

Retrieved on: 
Tuesday, September 22, 2020
FDA, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Bluebird bio, Bristol-Myers Squibb, Companies, Life sciences, Drugs, Bristol Myers Squibb, Squib, Breakthrough therapy, Orphan drugs, Elotuzumab, Antineoplastic drugs, Monoclonal antibodies

Together with our partners at Bristol Myers Squibb, we are committed to continue working with the FDA to deliver this promising therapy to patients in an expeditious manner.

Key Points: 
  • Together with our partners at Bristol Myers Squibb, we are committed to continue working with the FDA to deliver this promising therapy to patients in an expeditious manner.
  • Bristol Myers Squibb plans regulatory submissions for ide-cel in additional markets outside the U.S. and EU.
  • Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between Bristol Myers Squibb and bluebird bio.
  • Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): initial KarMMa results.

Opdivo (nivolumab) Demonstrated Superior Disease-Free Survival in Patients with Resected Esophageal or Gastroesophageal Junction Cancer Compared to Placebo in the Adjuvant Setting

Retrieved on: 
Monday, September 21, 2020
Biotechnology, Pharmaceutical, Health, Clinical trials, Clinical medicine, Drugs, Bristol-Myers Squibb, RTT, Medicine, Antineoplastic drugs, Breakthrough therapy, Monoclonal antibodies, Nivolumab, Ipilimumab, Esophageal cancer, Neoadjuvant therapy

The current standard of care for patients with esophageal or GEJ cancer following neoadjuvant CRT and tumor resection is surveillance.

Key Points: 
  • The current standard of care for patients with esophageal or GEJ cancer following neoadjuvant CRT and tumor resection is surveillance.
  • Adjuvant treatment with nivolumab in the CheckMate -577 trial doubled patients time without disease recurrence, representing the first adjuvant treatment advancement for these patients with esophageal or gastroesophageal junction cancer.
  • In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients.
  • In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

Opdivo (nivolumab) Plus Chemotherapy Demonstrated Significant Overall and Progression-Free Survival Benefits Versus Chemotherapy in First-Line Treatment of Gastric and Esophageal Cancers

Retrieved on: 
Monday, September 21, 2020
Other Health, Research, General Health, Pharmaceutical, Oncology, Hospitals, Clinical trials, Science, Biotechnology, FDA, Other Science, Health, Clinical medicine, Cancer, RTT, Antineoplastic drugs, Bristol-Myers Squibb, Lung cancer, Breakthrough therapy, Ipilimumab, Nivolumab, FOLFOX, Oxaliplatin, Chemotherapy

Patients in the Opdivo plus chemotherapy arm received Opdivo 360 mg plus capecitabine and oxaliplatin (CapeOX) every three weeks or Opdivo 240 mg plus 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX) every two weeks.

Key Points: 
  • Patients in the Opdivo plus chemotherapy arm received Opdivo 360 mg plus capecitabine and oxaliplatin (CapeOX) every three weeks or Opdivo 240 mg plus 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX) every two weeks.
  • By harnessing the bodys own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
  • OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.
  • OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.