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Important Update — Exkivity (mobocertinib): Globally Withdrawn. Exkivity's FDA approval was formally withdrawn on July 9, 2024, after the Phase 3 EXCLAIM-2 confirmatory trial failed to meet its primary endpoint (progression-free survival) when compared against standard chemotherapy. Takeda voluntarily withdrew Exkivity not only in the United States but initiated withdrawal globally, in every market where it was approved. As a result, Exkivity is no longer commercially available anywhere in the world, and NPP has no market from which to source it. This page is maintained for informational and historical reference only.
Before its withdrawal, Exkivity (mobocertinib) was approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease had progressed on or after platinum-based chemotherapy.
Exkivity was an oral tyrosine kinase inhibitor designed to selectively target EGFR exon 20 insertion mutations, a specific genetic alteration found in a subset of NSCLC patients that historically had limited targeted treatment options.
Patients previously on Exkivity, or newly diagnosed with EGFR exon 20 insertion-positive NSCLC, should consult their treating oncologist about currently available alternative therapies for this mutation, as treatment options and guidelines have evolved since Exkivity's withdrawal.
Boxed Warning — Exkivity: Exkivity can cause QTc interval prolongation and Torsades de Pointes, a life-threatening heart rhythm abnormality. Baseline and periodic ECG and electrolyte monitoring were required, along with avoidance of certain concomitant medicines known to prolong the QT interval. Dose adjustment or discontinuation was required based on the severity of QTc prolongation observed.
Interstitial lung disease or pneumonitis, which could be fatal, was a recognized risk. Treatment required immediate withholding if ILD/pneumonitis was suspected.
Exkivity could cause heart failure. A baseline cardiac assessment, including left ventricular ejection fraction, was required before starting treatment.
Diarrhea occurred in the majority of patients and required prompt treatment and monitoring, with dose modification as needed.
Exkivity was contraindicated in pregnancy due to the risk of fetal harm.
As Exkivity is no longer manufactured or commercially available anywhere in the world following its global withdrawal in 2024, none of the above information is actionable for new treatment decisions — it is provided for historical and informational context only.
Because Exkivity's approval has been withdrawn globally and the manufacturer, Takeda, has discontinued production and all clinical/expanded-access programs, NPP's standard import process does not currently apply to this medicine — there is no authorized market from which it can be sourced.
If regulatory status changes in the future in any market, or if a patient has a specific, documented clinical situation involving existing Exkivity supply, NPP's team can be contacted directly to discuss whether any pathway exists on a case-by-case basis. In the meantime, we recommend patients work with their treating oncologist to identify currently available, approved alternative therapies for EGFR exon 20 insertion-positive NSCLC.
Note: Because Exkivity cannot currently be sourced, the standard 6-step import process used for other medicines on this site does not apply here.
Exkivity is not currently available for import or sourcing through NPP, or through any other channel, anywhere in the world. Takeda voluntarily withdrew Exkivity's approval globally in 2024 following the EXCLAIM-2 confirmatory trial's failure to meet its primary endpoint, and has discontinued manufacturing.
Exkivity was manufactured and marketed by Takeda Pharmaceuticals America, Inc. prior to its withdrawal.
There is no market — regulated or otherwise — where Exkivity remains approved and commercially available. NPP does not source or supply Exkivity under any circumstances given this status.
NPP does not source or deliver Exkivity, as it has been withdrawn from every market worldwide and is no longer manufactured. This section is retained for transparency and informational completeness rather than to describe an active service.
Patients seeking treatment for EGFR exon 20 insertion-positive NSCLC should discuss currently available, approved alternative therapies with their treating oncologist, as the treatment landscape for this mutation has continued to evolve since Exkivity's withdrawal.
Exkivity is not available for import or sourcing anywhere in India, or anywhere in the world, following its global withdrawal. The information below reflects where patients can seek guidance on currently available alternative therapies, not Exkivity access.
Mumbai's oncology centers can advise patients on currently approved alternatives for EGFR exon 20 insertion-positive NSCLC.
Delhi's major hospitals can connect patients with oncologists familiar with current treatment options for this mutation.
Bangalore's oncology specialists can discuss currently available alternative therapies for eligible patients.
Chennai-based oncology specialists can advise on current treatment pathways for EGFR exon 20 insertion-positive NSCLC.
Hyderabad's care institutions can support patients seeking guidance on current treatment alternatives.
Kolkata's specialist centers can help patients understand currently available treatment options.
Pune-based specialists can advise on current alternatives for this specific NSCLC mutation.
Ahmedabad's specialty hospitals can guide patients toward currently approved treatment options.
Kochi's specialist units can assist patients in understanding current treatment alternatives.
Chandigarh's care centers can support patients from North India seeking current treatment guidance.
Jaipur's specialists can help patients navigate currently available treatment options.
Lucknow-based centers can assist patients in identifying current treatment alternatives.
Bhubaneswar's institutions can support patients seeking guidance on current options.
Guwahati's specialists can help coordinate guidance for patients across the Northeast.
NPP's team remains available to discuss currently sourceable alternative therapies for EGFR exon 20 insertion-positive NSCLC across India.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 16 September 2026
Sources: FDA
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 16 September 2026
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