A New Era in Cancer Treatment – Are Indian Patients Missing Out?
Recent years have seen a revolution in cancer care. Breakthrough therapies targeting specific mutations, immune checkpoint inhibitors, antibody-drug conjugates, and precision oncology drugs have transformed survival rates and quality of life for many patients. However, many of these new cancer medicines approved by the U.S. FDA and the European Medicines Agency (EMA) are not yet available in India.
This delay in local approval or commercial availability can be devastating for patients battling aggressive or resistant forms of cancer. Fortunately, there’s a legal and ethical way to access such life-saving medications before they are launched in India — via the Named Patient Program (NPP) you can Access FDA and EMA approved cancer drugs in India.
Recently Approved Cancer Drugs Not Yet Available in India
Here are some notable EMA and FDA-approved cancer medicines (2023–2025) that Indian patients may not have direct access to:
1. ORSERDU (elacestrant)
- Indication: ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
- FDA Approval: 2023
- India Status: Not commercially available.
- Why it matters: It is the first therapy targeting ESR1 mutations, often found in endocrine-resistant tumors.
2. RETSEVMO (selpercatinib)
- Indication: RET fusion-positive non-small cell lung cancer and thyroid cancer.
- FDA & EMA Approved: Yes
- India Status: Not available.
- Why it matters: Offers a targeted treatment option with high response rates and low toxicity.
3. COLUMVI (glofitamab)
- Indication: Relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
- EMA & FDA Approval: 2023
- India Status: Not launched.
- Why it matters: A bispecific antibody that brings new hope to heavily pre-treated DLBCL patients.
4. TIVDAK (tisotumab vedotin)
- Indication: Recurrent or metastatic cervical cancer after chemotherapy.
- FDA Approval: 2021
- India Status: Unavailable.
- Why it matters: Targets tissue factor – a new approach in cervical cancer therapy.
5. Blenrep (belantamab mafodotin)
- Indication: Relapsed/refractory multiple myeloma.
- FDA & EMA Approved: With conditions (ongoing reassessment).
- India Status: Not available.
- Why it matters: A novel antibody-drug conjugate for patients with no remaining standard options.
How Can Indian Patients Access These Medicines?
Under Indian CDSCO guidelines, patients with serious or life-threatening conditions can legally import unapproved drugs on a “named patient” basis, provided:
- The drug is approved in a regulated market (like the US or EU),
- There is no equivalent alternative in India,
- The treating physician certifies the need, and
- The patient or caregiver is willing to bear the cost.
Required Documents for NPP Import:
- Doctor’s prescription and clinical summary
- Patient’s ID and consent
- Form 12B for personal import (filed with CDSCO)
- Import permit approval from the licensing authority
- Customs clearance at the port of entry
This process can be daunting for families, especially when time is of the essence. That’s where MitoGENE plays a crucial role.
How MitoGENE Supports Patients Accessing Global Cancer Treatments
At MitoGENE, we specialize in helping cancer patients in India access EMA/FDA-approved medications not yet available locally, through our comprehensive Named Patient Program (NPP) services. We simplify the process so patients and caregivers can focus on care, not paperwork.
What We Do:
✅ Verify eligibility of the patient and drug under NPP guidelines
✅ Coordinate with global suppliers and licensed distributors
✅ Assist with CDSCO documentation and import approvals
✅ Ensure secure, temperature-controlled logistics
✅ Track shipment and ensure last-mile delivery to the treating hospital
✅ Offer compassionate pricing support wherever possible
We act as a bridge between cutting-edge global science and the individual patient who needs it, urgently and ethically.
Final Thoughts
If you or your loved one is facing a cancer diagnosis where standard treatments have failed or no longer work, you deserve access to the latest advances in global oncology. New medicines are being approved every month by international regulatory bodies, and many of them show incredible promise — even for difficult-to-treat cancers.
Don’t let geography limit your options. Let MitoGENE help you explore safe, compliant, and timely access to these breakthrough therapies.
📞 Reach Out Today
If you’re a patient, caregiver, or clinician seeking a specific cancer treatment that is not available in India, contact our Named Patient Program team:
📧 Email: info@mitogene.org
🌐 Visit: www.mitogene.org/named-patient-program
📞 Helpline: +91-9941034386
Hope starts with access. And access starts with MitoGENE.