Mirati Therapeutics: cross-border access for the specialty portfolio
Quick orientation
Mirati Therapeutics, Inc. was a US precision oncology company headquartered in San Diego, California, focused on KRAS, MTAP, and PRMT5-driven cancers. Mirati was acquired by Bristol Myers Squibb in January 2024 for approximately US$4.8 billion, and its commercial and clinical operations are now integrated into BMS oncology. The lead asset Krazati (adagrasib) - the second KRAS G12C inhibitor approved by the FDA - is now a BMS-commercialised product. FDA approval scale post-acquisition is one marketed product with two distinct indications, and the pipeline (including the KRAS G12D candidate MRTX1133, advanced solid tumor candidates, and other selective inhibitors) is advancing within BMS development. The integration places Mirati's clinical and commercial work alongside BMS's existing oncology franchise, including Opdivo, Yervoy, and the cell therapy and oncology hematology portfolios.
Mirati / BMS portfolio in cross-border NPP scope
Krazati (adagrasib) is an FDA-approved oral KRAS G12C inhibitor for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy (FDA accelerated approval December 2022). In June 2024, the FDA approved Krazati in combination with cetuximab for previously treated KRAS G12C-mutated metastatic colorectal cancer. Oral dosing, twice daily. US list pricing is approximately US$19,750 per month. KRAS G12C mutations occur in roughly 13 percent of NSCLC and 3 to 4 percent of colorectal cancers, making this a significant subpopulation with a previously undruggable target. Krazati joined Lumakras (sotorasib, Amgen) as the second commercial KRAS G12C inhibitor and offers distinct pharmacokinetic and tolerability characteristics that inform sequence-of-therapy decisions.
The combination of Krazati with cetuximab is particularly relevant for metastatic colorectal cancer patients with KRAS G12C, who historically had poor response rates to standard chemotherapy and limited targeted options. The KRYSTAL-1 and KRYSTAL-12 trials provided the clinical evidence base for the combination indication.
Mirati's pipeline candidate MRTX1133 (KRAS G12D inhibitor) is investigational and not in NPP scope. Additional Mirati legacy candidates and BMS-led development continue inside the integrated BMS oncology pipeline.
Why patients route through cross-border NPP
KRAS G12C status is now a routinely tested biomarker in NSCLC and colorectal cancer in major reference labs worldwide, including most GCC and Indian academic centers. However, the commercial availability of Krazati outside the United States is uneven. The European Commission granted conditional approval for Krazati in NSCLC in January 2024, but country-by-country reimbursement and supply remain inconsistent. In India, the GCC, Turkey, and most of Latin America, confirmed-mutation patients face a registration-and-reimbursement gap during which cross-border NPP from US inventory is frequently the only viable supply.
Patient profile is typically: confirmed KRAS G12C by next-generation sequencing performed at a recognised molecular pathology lab; progression after first-line platinum-based chemotherapy with or without immunotherapy for NSCLC, or progression on prior systemic therapy for colorectal cancer; performance status preserved; and family or self-pay capacity for oral targeted therapy at approximately US$20,000 per month landed cost. Many patients in our inbound flow have already failed Lumakras (sotorasib) and are seeking the alternative KRAS G12C inhibitor.
Common cross-border destinations
The highest-frequency NPP destinations for Krazati from US-approved inventory are India, the United Arab Emirates, Saudi Arabia, Turkey, and Egypt. Major thoracic oncology and GI oncology centers in Mumbai, Bangalore, Hyderabad, Delhi, Dubai, Riyadh, and Istanbul drive most inbound referrals.
Manufacturer engagement posture
Reserve Meds coordinates Mirati/BMS-sourced US commercial product through DSCSA-compliant US specialty distributors. We are not affiliated with BMS or with the legacy Mirati commercial organization. Our role is patient-facing coordination on behalf of named individual patients with a verified oncology prescription. For BMS medical affairs or commercial teams interested in cross-border NPP pathways for Krazati, our BD contact is [email protected].
What Reserve Meds provides
For each Krazati request, Reserve Meds coordinates: prescription verification with the treating oncologist; KRAS G12C testing documentation review (NGS panel report from a recognised lab); DSCSA serialized chain-of-custody from BMS through licensed US wholesalers to the named patient; ambient shipping with appropriate packaging; destination-country regulatory documentation for Ministry of Health named-patient approvals and customs clearance; and a dedicated coordinator from prescription to delivery.
Clinical governance and prescription review
Every prescription for a product on this page is reviewed by a US-licensed pharmacist before dispensing. Reserve Meds does not substitute generic equivalents for branded specialty products without an explicit prescriber instruction, and we do not dispense any product whose chain-of-custody we cannot serialize back to the FDA-authorised manufacturer or its licensed wholesale partner. Our clinical review confirms indication-on-label appropriateness based on the documentation submitted by the treating physician, identifies any standard drug-drug interaction or contraindication concerns, and confirms that the requested dose, dosing schedule, and dosage form match the prescription. Where the prescription is unclear or where the indication on the prescription is off-label, our pharmacist contacts the prescriber directly. We do not provide medical advice to patients beyond drug-information counseling at dispensing.
Supply chain integrity
Supply integrity is the foundation of Reserve Meds operations. Every shipment carries a serialized DSCSA pedigree document confirming the chain of ownership from the FDA-registered manufacturer or its authorised distributor through a licensed US wholesale distributor to Reserve Meds and onward to the named patient. We do not source through parallel-import channels, third-country re-import, or unverified online wholesale markets. Cold-chain shipments are packed in qualified shippers with temperature data-loggers reading and logging temperature throughout the journey; data-logger reads are reviewed on arrival, and any out-of-specification excursion triggers our quality-hold protocol. For frozen products such as gene therapies and certain antibody-drug conjugates, we use validated frozen-shipper systems with dry-ice replenishment as required.
Destination-country regulatory pathways
Cross-border named patient access operates under jurisdiction-specific regulatory frameworks. In the United Arab Emirates, the Ministry of Health and Prevention (MOHAP) and Dubai Health Authority operate import-permit pathways for unregistered or restricted medicines on a named-patient basis. Saudi Arabia, Qatar, Kuwait, Bahrain, and Oman each operate analogous Ministry of Health named-patient frameworks with country-specific documentation requirements. India operates a personal-import pathway under the Drugs and Cosmetics Rules for quantities consistent with personal therapeutic use, typically up to three months supply per shipment. Turkey, Egypt, Jordan, Lebanon, and Morocco each operate distinct named-patient or import-permit pathways. Reserve Meds maintains current regulatory intelligence for each of these jurisdictions and prepares the documentation package required for each shipment.
What to expect through the coordination process
Patients beginning a request receive an initial coordinator contact within one business day of submission. The coordinator reviews the prescription, identifies the documentation required for the destination country, and provides an indicative cost range. Once required documents are uploaded - prescription, prescriber license verification, patient identification, and any indication-specific documentation such as genetic test results or biomarker reports - we issue a firm quote inclusive of product cost, packaging, shipping, regulatory documentation, and our coordination fee. Patients confirm acceptance of the firm quote before any sourcing or shipping is initiated, and Reserve Meds does not collect any deposit at intake. Once the firm quote is accepted and payment is received, the coordinator initiates sourcing through our licensed wholesale partners and prepares the destination-country regulatory package. Typical end-to-end timing from accepted quote to delivery is two to four weeks for ambient-shipped products and three to five weeks for cold-chain shipments, with variability driven by destination-country customs and regulatory turnaround times.
Not affiliated with the manufacturer
Reserve Meds is an independent operator of named patient program coordination. We are not a subsidiary, affiliate, authorised distributor, or licensed representative of any pharmaceutical manufacturer, and no statement on this page should be read as a partnership, endorsement, or representation by the named manufacturer. Trade names and product references on this page are used for informational purposes to identify the FDA-approved products that Reserve Meds coordinates through US specialty wholesale channels on behalf of named individual patients.
Privacy and data handling
Patient data submitted to Reserve Meds is handled under our HIPAA-aligned privacy policy and our destination-country data protection commitments. We minimise data collection to what is necessary for prescription verification, regulatory documentation, and shipping logistics. Patient identifiable information is shared with US wholesalers, destination-country regulatory authorities, and shipping carriers only as required to complete the coordination, and is not used for any marketing purpose.
Next step for patients
Patients with confirmed KRAS G12C NSCLC or metastatic colorectal cancer and a treating-oncologist prescription for Krazati can begin a request now. Start a Krazati request ›
Next step for BMS / Mirati teams
BMS oncology medical affairs or commercial teams can reach our BD team at [email protected].
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