Antineoplastic drugs

FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer

Retrieved on: 
Wednesday, June 30, 2021
Clinical medicine, Medicine, Antineoplastic drugs, Cancer, Cancer treatments, Asparaginase, Chemotherapy, Leukemia, 7+3

"Today's approval may provide a consistently sourced alternative to a pivotal component of potentially curative therapy for children and adults with this type of leukemia."

Key Points: 
  • "Today's approval may provide a consistently sourced alternative to a pivotal component of potentially curative therapy for children and adults with this type of leukemia."
  • It is the most common type of childhood cancer.
  • One component of the chemotherapy regimen is an enzyme called asparaginase that kills cancer cells by depriving them of substances needed to survive.
  • The most common side effects of Rylaze include hypersensitivity reactions, pancreatic toxicity, blood clots, hemorrhage and liver toxicity.

Cytovation Announces Clinical Collaboration with MSD to Evaluate its First-in-class Tumorolytic Agent CyPep-1 in Combination with KEYTRUDA®

Retrieved on: 
Wednesday, June 30, 2021
Cancer treatments, Clinical medicine, Medicine, Antineoplastic drugs, Cancer immunotherapy, Biotechnology, Breakthrough therapy, Pembrolizumab, Pelareorep

Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort.

Key Points: 
  • Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort.
  • We are very pleased to be collaborating with MSD as we explore the potential of this combination in patients."
  • CyPep-1 is a proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal cells.
  • Cytovation AS is a privately held, clinical stage immune-oncology company focused on the development of CyPep-1, a first-in-class tumorolytic agent targeting the cell membrane of tumor cells.

Cytovation Announces Clinical Collaboration with MSD to Evaluate its First-in-class Tumorolytic Agent CyPep-1 in Combination with KEYTRUDA®

Retrieved on: 
Wednesday, June 30, 2021
Cancer treatments, Clinical medicine, Medicine, Antineoplastic drugs, Cancer immunotherapy, Biotechnology, Breakthrough therapy, Pembrolizumab, Pelareorep

Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort.

Key Points: 
  • Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort.
  • We are very pleased to be collaborating with MSD as we explore the potential of this combination in patients."
  • CyPep-1 is a proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal cells.
  • Cytovation AS is a privately held, clinical stage immune-oncology company focused on the development of CyPep-1, a first-in-class tumorolytic agent targeting the cell membrane of tumor cells.

Cend Therapeutics’ CEND-1 Granted Fast Track Designation for Pancreatic Cancer

Retrieved on: 
Tuesday, June 29, 2021
Food and Drug Administration, Clinical medicine, Medicine, Orphan drugs, Drugs, Antineoplastic drugs, Peptides, iRGD, Accelerated approval, Pancreatic cancer, Fast track, Priority review

CEND-1 was granted Orphan Drug Designation by the FDA for the treatment of pancreatic cancer in January 2019.

Key Points: 
  • CEND-1 was granted Orphan Drug Designation by the FDA for the treatment of pancreatic cancer in January 2019.
  • By awarding Fast Track Designation, the FDA has recognized CEND-1s potential to meaningfully improve outcomes for pancreatic cancer patients,said Andrew Dorr, MD, Chief Medical Officer of Cend.
  • Fast Track designation can lead to an Accelerated Approval and Priority Review if certain criteria are met.
  • Cend is also applying its technology to alter immunosuppression selectively within the tumor microenvironment to enable a patients immune system and immunotherapies to more effectively fight cancer.

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy

Retrieved on: 
Tuesday, June 29, 2021
Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Infectious diseases, Clinical trials, Drugs, Clinical medicine, Cancer treatments, Bristol-Myers Squibb, Breakthrough therapy, Orphan drugs, Antineoplastic drugs, Monoclonal antibodies, Ipilimumab, Nivolumab, Bristol Myers Squibb, Melanoma

Bristol Myers Squibb (NYSE: BMY) announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy.
  • Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
  • 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.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for Certain Patients With Esophageal Cancer or HER2-Negative Gastroesophageal Junction (GEJ) Adenocarcinoma

Retrieved on: 
Tuesday, June 29, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Clinical medicine, Cancer treatments, Medicine, Breakthrough therapy, Antineoplastic drugs, Orphan drugs, Cancer, Pembrolizumab, Trastuzumab, Microsatellite instability, HER2/neu, Esophageal cancer

Esophageal cancer is the eighth most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide.

Key Points: 
  • Esophageal cancer is the eighth most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide.
  • KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
  • The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
  • KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

ORIC Pharmaceuticals Announces FDA Clearance of IND Application for ORIC-533, a Highly Potent, Orally Bioavailable Small Molecule CD73 Inhibitor

Retrieved on: 
Monday, June 28, 2021
Clinical medicine, Medicine, Medical specialties, Clusters of differentiation, Antineoplastic drugs, Oncology, NT5E, Adenosine, Chemotherapy

ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy and immunotherapy-based treatment regimens.

Key Points: 
  • ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy and immunotherapy-based treatment regimens.
  • In preclinical studies, ORIC-533 has demonstrated higher potency within a high AMP environment compared to all CD73 and adenosine receptor inhibitors against which it was compared.
  • ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy and immunotherapy-based treatment regimens.
  • ORIC-533 has demonstrated greater potency in preclinical studies compared to an antibody approach, other small molecule CD73 inhibitors and inhibitors of adenosine receptors.

Exelixis and Ipsen Announce Cabozantinib in Combination with an Immune Checkpoint Inhibitor Significantly Improved Progression-Free Survival in Phase 3 COSMIC-312 Pivotal Trial in Patients with Previously Untreated Advanced Liver Cancer

Retrieved on: 
Monday, June 28, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Orphan drugs, Drugs, Organic compounds, Antineoplastic drugs, Tyrosine kinase inhibitors, Cabozantinib, Cyclopropanes, Quinolines, Exelixis, Ipsen, Sorafenib, COSMIC-312, HCC, CABOMETYX® (cabozantinib), Ipsen, COSMIC-312, HCC, CABOMETYX® (CABOZANTINIB), IPSEN

Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).

Key Points: 
  • Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).
  • In the European Union, CABOMETYX is also approved in combination with nivolumab as first line treatment for patients living with advanced RCC.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.

Exelixis and Ipsen Announce Cabozantinib in Combination with an Immune Checkpoint Inhibitor Significantly Improved Progression-Free Survival in Phase 3 COSMIC-312 Pivotal Trial in Patients with Previously Untreated Advanced Liver Cancer

Retrieved on: 
Monday, June 28, 2021
Research, FDA, Clinical trials, Other Health, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Chemical compounds, Orphan drugs, Drugs, Organic compounds, Antineoplastic drugs, Tyrosine kinase inhibitors, Cabozantinib, Cyclopropanes, Quinolines, Exelixis, Ipsen, Sorafenib, COSMIC-312, HCC, CABOMETYX® (cabozantinib), Ipsen, COSMIC-312, HCC, CABOMETYX® (CABOZANTINIB), IPSEN

Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).

Key Points: 
  • Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).
  • In the European Union, CABOMETYX is also approved in combination with nivolumab as first line treatment for patients living with advanced RCC.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.

Polyphor Provides Update on the Phase III FORTRESS Study of Balixafortide in Patients With Advanced HER2 Negative Breast Cancer

Retrieved on: 
Monday, June 28, 2021
Clinical medicine, Drugs, Cancer treatments, Antineoplastic drugs, Orphan drugs, HER2/neu, Eribulin, Breast cancer, Metastatic breast cancer, Trastuzumab emtansine, Pertuzumab

The study confirmed the positive safety and tolerability profile of balixafortide in line with the previously reported Phase Ib study.

Key Points: 
  • The study confirmed the positive safety and tolerability profile of balixafortide in line with the previously reported Phase Ib study.
  • Given the high unmet medical need for patients with HER2 negative breast cancer in a late stage of the disease, we are disappointed that the FORTRESS study did not meet its coprimary endpoint, says Gkhan Batur, CEO of Polyphor.
  • The FORTRESS study (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial which investigates the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, locally recurrent or metastatic breast cancer.
  • The study had randomized 432 patients with HER2 negative MBC with at least 344 patients receiving third or subsequent line and 88 patients receiving second line chemotherapy.