6 days ago
FDA Approves Rasonque, Landmark Pill for Advanced Pancreatic Cancer
The United States approved a new pill called daraxonrasib, sold as Rasonque, for some people with advanced pancreatic cancer.
It is taken once a day.
The medicine blocks RAS proteins, including KRAS, which can help cancer cells grow.
In a study, people taking the pill lived a median of 13.2 months, compared with 6.7 months for people receiving chemotherapy.
A median is a middle result, so it does not mean every person will live that long or that each person’s life will double.
The drug is for cancer that has spread and stopped responding to earlier treatment, or for people unable to receive several medicines together.
It is not a replacement for surgery or standard treatment in newly diagnosed, potentially operable cancer.
Side effects can include rash, diarrhea, mouth inflammation, nausea and tiredness, among others.
The medicine costs about $39,800 per month in the United States and is not automatically available in India.
The US Food and Drug Administration approved once-daily daraxonrasib, marketed by Revolution Medicines as Rasonque, for certain adults with metastatic pancreatic adenocarcinoma.
In a 500-patient company-funded study, median survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy.
The drug targets multiple forms of RAS proteins, including KRAS mutations that help drive pancreatic tumor growth.
Approval covers patients whose cancer has spread after at least one prior systemic treatment, or who are not candidates for multiagent therapy.
A 30-day US supply costs about $39,800, while Indian access depends on local approval, importation, marketing and reimbursement decisions.
- Who
- The US Food and Drug Administration approved daraxonrasib for certain adults with metastatic pancreatic adenocarcinoma; Revolution Medicines makes and markets the drug as Rasonque.
- What
- Daraxonrasib received expedited approval as a once-daily oral treatment targeting multiple forms of RAS proteins.
- Where
- The approval applies in the United States; access in India remains subject to local regulatory and commercial decisions.
- When
- The approval was announced on a Wednesday; the articles do not provide a calendar date.
- Why
- A company-funded study found longer median overall survival and progression-free-survival benefits compared with chemotherapy in eligible patients whose metastatic cancer had stopped responding to prior treatment.
Evidence and Treatment Promise
Limitations and Access Concerns
Clinical benefit
Evidence and Treatment Promise
The trial showed median survival of 13.2 months with daraxonrasib compared with 6.7 months with chemotherapy, and reported benefits in progression-free survival and patient-reported quality of life.
Limitations and Access Concerns
The result is a population median, not a guarantee that an individual patient will live twice as long; some patients may not respond or may stop treatment because of toxicity.
Role in treatment
Evidence and Treatment Promise
Doctors described the approval as a significant improvement and a breakthrough against a difficult cancer, while the drug’s RAS-targeting approach could encourage further research in other cancers.
Limitations and Access Concerns
The drug is not a cure and is not approved as a universal first treatment; surgery, chemotherapy and radiotherapy remain relevant where appropriate.
Availability and affordability
Evidence and Treatment Promise
US approval gives eligible patients a new oral treatment option, and expedited review made it available more than six months ahead of the FDA’s target date.
Limitations and Access Concerns
The listed US price is about $39,800 per month, and approval does not automatically make the medicine routinely available in India; insurance, importation, local approval and reimbursement will affect access.
Key facts
- Drug
- Daraxonrasib, marketed under the brand name Rasonque
- Approved population
- Adults with metastatic pancreatic adenocarcinoma after at least one prior systemic treatment, or adults who are not candidates for multiagent systemic therapy
- Study size
- 500 patients with metastatic cancer that had stopped responding to prior treatment
- Median overall survival
- 13.2 months with daraxonrasib versus 6.7 months with chemotherapy
- Reported hazard ratio
- About 0.40 for death during the study period
- Common adverse effects
- Rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite and hemorrhage
- US wholesale acquisition cost
- Approximately $39,800 for a 30-day supply, or about $477,600 annually before insurance adjustments
Quotes
Dr. Andrew Coveler
Physician at the Fred Hutch Cancer Center
“I think this has opened doors for many other companies. Downstream I think there are going to be a lot more trials looking at this approach in other tumor types.”
livemint.com
“This is one of the most anticipated approvals I can think of. This medicine is not a cure but a significant improvement.”
livemint.com
Kyle Diamantas
Acting commissioner of the US Food and Drug Administration
“It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible”
livemint.com
Sources
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