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New Cancer Treatments Are Within Reach — Here’s How Indian Patients Can Get Them

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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:

  1. Doctor’s prescription and clinical summary
  2. Patient’s ID and consent
  3. Form 12B for personal import (filed with CDSCO)
  4. Import permit approval from the licensing authority
  5. 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.

NERLYNX (Neratinib) for HER2+ve Breast Cancer: Reduce Recurrence Risk and Access It Legally in India

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A HER2+ve breast cancer diagnosis can feel devastating. But with modern breakthroughs in targeted therapies, thousands of women now complete treatment and go on to live healthy, fulfilling lives. Yet, one concern often lingers in the minds of survivors: “Will the cancer come back?”
That’s where NERLYNX® (neratinib) steps in—as a powerful next step designed to reduce the risk of breast cancer recurrence after standard therapy.

What Is NERLYNX and How Does It Work?

NERLYNX is an oral targeted therapy prescribed after completing HER2-directed treatment like trastuzumab (Herceptin). It belongs to a class of medicines known as tyrosine kinase inhibitors (TKIs), which help to block HER2 signaling—a key driver in HER2-positive breast cancer cell growth.

Approved by:

  • U.S. FDA (2017)
  • European Medicines Agency (EMA) (2018)

Indication:

  • Extended adjuvant treatment in early-stage HER2-positive breast cancer, especially for hormone receptor-positive women.

Form:

Oral tablets, taken once daily for 12 months.

NERLYNX in Clinical Trials: Real Data That Matters

In the landmark ExteNET Phase III clinical trial, 2,840 women who had finished one year of trastuzumab were given NERLYNX.

Key Results from the ExteNET Study:

• 💪 34% lower risk of invasive disease recurrence

• 💡 Greatest benefit seen in hormone receptor-positive patients

• 🧠 Lower risk of distant metastases—including in the brain—over 5 years

Source: The Lancet Oncology, 2016

Real Patient Experience: Meena’s Journey from Uncertainty to Confidence:

Meena, a 45-year-old mother from Bangalore, completed surgery, chemotherapy, and one year of trastuzumab. Her doctor recommended NERLYNX due to her HER2+ and hormone receptor-positive profile.

Though she experienced mild diarrhoea at the start, it was well-managed with supportive medication. She completed her full 12-month course—and remains cancer-free three years later.

Who Should Consider NERLYNX?

NERLYNX may be suitable for patients who:

  • Have early-stage HER2-positive breast cancer
  • Completed trastuzumab within the past 12 months
  • Are hormone receptor-positive
  • Have node-positive disease or large tumors—high-risk profiles for recurrence

What are the Side Effects—and How to Manage Them?

The most common side effect is diarrhea, especially during the first few weeks of treatment. However, early and proactive management makes a big difference.

Common Side Effects:

  • Diarrhea (~93%, but only ~40% severe)
  • Nausea
  • Abdominal pain
  • Fatigue
  • Vomiting

Tip: Oncologists usually recommend starting loperamide (Imodium) from Day 1 to help control this.

Is NERLYNX AvaiIs NERLYNX Available in India?

Currently, NERLYNX is not commercially available in Indian pharmacies. However, patients can access it legally and ethically through the Named Patient Program (NPP)—a government-permitted import mechanism for unapproved medications in special cases.

At MitoGENE, we specialize in helping Indian patients access critical therapies not available locally.

We provide:

  • 📄 End-to-end support with regulatory documentation
  • 🤝 Coordination with your treating doctor
  • 🚚 Legal import and cold-chain delivery of NERLYNX to your city
  • 🔒 Full compliance with Indian laws and patient safety standards

A Story of Access: Anita’s Path to Treatment

Anita, 39, from Mumbai, needed NERLYNX after completing her HER2+ breast cancer treatment. Local pharmacies couldn’t help, but through MitoGENE’s Named Patient Program, Anita’s medicine was safely imported from Europe, delivered with all clearances—and her treatment started right on time.

Final Thoughts: Taking the Next Step After HER2+ Breast Cancer

If you or a loved one has completed treatment for HER2-positive breast cancer and you worry about recurrence, NERLYNX could offer peace of mind. While not yet available off the shelf in India, MitoGENE ensures patients can access it safely, legally, and reliably.

Talk to your oncologist today. And if NERLYNX is right for you, we’re here to walk the journey with you—step by step.

Need Help Accessing NERLYNX in India?
Contact MitoGENE today for personalized assistance and regulatory support.

Mobile / Whatsapp: +91-9944424386, +91-9941034386 | Email: info@mitogene.org

Disclaimer: This information is based on open sources and does not replace medical advice. Always consult your treating doctor before starting any treatment. MitoGENE facilitates access under Indian regulations but does not prescribe or promote medicines.