QINLOCK® (ripretinib) Access
For Advanced GIST After Multiple Treatment Failures
Patient Background
A 46-year-old patient from Udaipur, Rajasthan, was living with Gastrointestinal Stromal Tumour (GIST) for over six years. After exhausting approved therapies including imatinib, sunitinib, and regorafenib, disease progression was confirmed.
The patient’s oncologist recommended QINLOCK® (ripretinib)—a switch-control tyrosine kinase inhibitor approved USFDA and EMA for 4th-line GIST.
Barriers to Access
Qinlock was unavailable in India, which limited the patient’s access to the required treatment.
- Lack of local supply
- Uncertainty around legal imports
- High international pricing without structured support
MitoGENE was approached to facilitate access under the Named Patient Program.
Regulatory Compliance & Planning
MitoGENE verified:
- Patient eligibility under Indian NPP regulations
- Valid prescription and treatment rationale
- Import permissibility
A structured regulatory roadmap was shared with the family, explaining timelines, approvals, and responsibilities clearly.
Import & Logistics Management
- Authentic sourcing from EU-authorised distributors
- Batch traceability
- Customs declaration under life-saving drug exemption
MitoGENE managed end-to-end coordination with Indian customs, reducing clearance time significantly.
Clinical Response
Qinlock was successfully imported and administered as per the treatment plan. The patient tolerated therapy well and continued treatment under close medical supervision.
MitoGENE’s Value Addition
- Regulatory navigation
- Price benchmarking from EU suppliers
- Continuity planning for refills
- Ongoing patient support
This case underscores how NPP acts as a bridge between innovation and unmet medical need in India.
Disclaimer: The product mentioned is not approved for commercial sale in India. Access was provided strictly for personal use under physician supervision in accordance with CDSCO’s Named Patient Program (Form 12B). MitoGENE does not promote or sell unapproved drugs.