Last week we saw some FDA approvals come through, as well as research that explored the psychosocial outcomes of individuals who survived pediatric rhabdosarcoma. And finally, we’ll discuss another cancer vaccine clinical trial that got the green light from the Food and Drug Administration.
Topics discussed:
- 0:59 FDA approves Besponsa for pediatric acute lymphoblastic leukemia
- 2:42 Opdivo-chemotherapy regimen gets FDA approval for metastatic bladder cancer
- 4:39 Brukinsa plus Gazyva gains approval for relapsed/refractory follicular lymphoma
- 5:25 Psychological outcomes in rhabdomyosarcoma survivors
- 6:05 Ovarian cancer vaccine trial is OK to proceed
FDA Approved Besponsa for Children With Acute Lymphoblastic Leukemia
The first FDA approval of last week was one in the pediatric cancer space. The agency approved Besponsa for children who are at least 1 year old and have relapsed or refractory CD22-positive precursor acute lymphoblastic leukemia., also known as ALL.
The approval is coming after findings from a single-arm study involving 53 children. Of which, 22 — that’s 42% — achieved a complete response from the therapy, with the median duration of complete response being 8.2 months. Additionally, the majority of patients who achieved a complete response also had minimal residual disease negativity, which indicates that there were 5% or less blasts found in the bone marrow and no cancer cells detected in the blood.
Having a new treatment option for children with ALL is particularly exciting, as ALL is one of the most common pediatric cancers, according to the American Cancer Society.
FDA Approves Opdivo Plus Chemo for Unresectable or Metastatic Bladder Cancer
Last week, the FDA also approved an immunotherapy/chemotherapy regimen for certain patients with bladder cancer. Specifically, the agency OKed Opdivo plus cisplatin and gemcitabine for the frontline treatment of adults with unresectable or metastatic urothelial carcinoma.
This approval was backed by findings from the CheckMate-901 trial, which showed that the Opdivo-chemotherapy regimen improved overall survival (which is the time patients live before death of any cause) and progression-free survival (which is the time patients live without their disease worsening) compared to those who did not receive Opdivo. The median overall survival was 21.7 months for those who received Opdivo compared to 18.9 months for those who did not, while progression-free survival was 7.9 and 7.6 months, respectively.
FDA Approves Brukinsa, Gazyva Combo for Relapsed, Refractory Follicular Lymphoma
Last week, the Food and Drug Administration also approved Brukinsa plus Gazyva for patients with relapsed or refractory follicular lymphoma after findings from the ROSEWOOD trial showed that not only did more patients respond to the two-drug treatment compared to Gazyva alone, but also at a median follow-up of 19 months, more patients were still responding compared to the Gazvya arm as well.
Rhabdomyosarcoma Survivors May Have Poor Psychological Outcomes
A study published in the journal, Cancer, found that survivors of rhabdomyosarcoma — which is a rare cancer affecting soft tissues — may face increased risk of psychological challenges, especially if they were exposed to previous radiation therapy or have a history of smoking.
Researchers examined neurocognitive impairment, emotional distress and health-related quality of life in survivors compared to their siblings. Results showed higher rates of issues like memory impairment and emotional distress among survivors, with smoking linked to poorer outcomes. The CURE® team spoke with study author, Ellen van der Plas on the findings. Here is what she had to say.
Ovarian Cancer Vaccine Trial Gets FDA Clearance to Proceed
The FDA has given the green light for a clinical trial of a vaccine designed to treat advanced ovarian cancer. Known as Innocell, this personalized therapy utilizes cells from the patient’s own tumor which is inactivated via riboflavin and UV light. The drug is being manufactured at City of Hope in Los Angeles, and the trial aims to assess the vaccine’s safety and effectiveness in stimulating immune response.
This is one of the many cancer vaccines being explored and developed in the oncology space. Check back on prior CURE® coverage for updates on vaccines to treat breast, lung, skin and other cancers.
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