FDA Approves Opdivo as First Immunotherapy for Gastric Cancer
A randomized trial found that the median survival for patients treated with the immunotherapy lived over two months longer than those who received chemotherapy alone.
FDA recently approved Opdivo, making it the first immunotherapy for initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
The agency based its approval on the randomized, multicenter trial of 1,581 patients with previously untreated gastric cancer.
In the trial, 789 patients who received Opdivo in combination with chemotherapy lived longer than the 792 patients who received chemotherapy alone.
Specifically, the median survival was 13.8 months for patients who received Opdivo plus chemotherapy, compared to 11.6 months for patients who received chemotherapy alone.
With currently available therapy for gastric cancer, the survival rate for all stages is 32 percent and the five-year survival rate for advanced or metastatic gastric cancer is five percent. Therefore, FDA’s approval is a crucial improvement in the treatment of this disease.
“Today’s approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time,” Richard Pazdur, MD, director of FDA’s oncology center of excellence and acting director of the office of oncologic diseases in the agency’s center for drug evaluation and research, said in the announcement.
“The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer,” Pazdur continued.
The most common side effects of Opdivo in combination with chemotherapy include peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain.
In May, FDA accepted Bristol Myer Squibb’s supplemental Biologics License Application for Opdivo in combination with chemotherapy.
The filing was based on results from the Phase 3 CheckMate-649 trial.
In the trial, treatment with Opdivo plus chemotherapy led to a statistically significant improvement in overall survival and progression-free survival for patients with gastric cancer, compared to treatment with chemotherapy alone.
FDA Grants De Novo Clearance for Oxehealth’s Medical Device
Oxehealth recently announced that FDA granted De Novo clearance for its patient monitoring and management platform, Oxehealth Vital Signs product.
The platform, which is delivered as a software as a service, is now available on the market in all US states. It will be deployed in skilled nursing facilities to help clinicians improve safety, quality, and efficiency of care.
Hugh Lloyd-Jukes, chief executive officer of Oxehealth, said that the company is excited to begin partnering with clinicians and the leadership teams of healthcare providers in America to provide them with safer and most cost-efficient care.
FDA Approves Roche’s Biologic License Application for Xolair
Roche recently announced that FDA approved its Biologic License Application for Xolair, a prefilled syringe for self-infection across all approved US indications.
Xolair is currently the only FDA-approved biologic designed to target and block immunoglobulin for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria, and nasal polyps.
Before starting self-injecting Xolair, the patient must have no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections with no hypersensitivity, a Roche spokesperson explained.
After Xolair, a healthcare provider can determine whether self-injection with Xolair by the patient or caregiver is appropriate.
But the provider must train the patient on the correct injection technique, as well as how to recognize the signs and symptoms of anaphylaxis and how to treat anaphylaxis properly.
Nearly 460,000 patients have been treated in the US with Xolair since its initial approval in 2003.
“Expanding treatment options for personalised care and self-management is always welcome news for the patient community,” said Kenneth Mendez, CEO and president of the Asthma and Allergy Foundation of America.
“The possibility of administering FDA-approved treatment outside of the healthcare provider’s office, but still guided by that healthcare provider, may reduce barriers to care for patients and their caregivers,” Mendez continued.
