Tepotinib

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Tepotinib
Clinical data
Trade namesTepmetko
Other namesEMD-1214063
AHFS/Drugs.comMonograph
MedlinePlusa621012
License data
Pregnancy
category
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
  • 3-{1-[(3-{5-[(1-methylpiperidin-4-yl)methoxy]pyrimidin2-yl}phenyl)methyl]-6-oxo-1,6-dihydropyridazin3-yl}benzonitrile
JSmol)
  • CN1CCC(COc2cnc(-c3cccc(Cn4nc(-c5cccc(C#N)c5)ccc4=O)c3)nc2)CC1
  • InChI=1S/C29H28N6O2/c1-34-12-10-21(11-13-34)20-37-26-17-31-29(32-18-26)25-7-3-5-23(15-25)19-35-28(36)9-8-27(33-35)24-6-2-4-22(14-24)16-30/h2-9,14-15,17-18,21H,10-13,19-20H2,1H3
  • Key:AHYMHWXQRWRBKT-UHFFFAOYSA-N

Tepotinib, sold under the brand name Tepmetko, is an

non-small cell lung cancer (NSCLC).[4][5][8]

The most common side effects include edema (build-up of fluid), nausea (feeling sick), low albumin level in the blood, diarrhea, and increase in creatinine level in the blood (a sign of kidney problems).[6]

Tepotinib first received marketing approval in Japan, in March 2020, as a "line-agnostic" drug, meaning it is approved both for treatment-naive patients and for those in whom previous attempts at treatment have failed.[9] US approval followed in February 2021. It is the second therapy approved by the US Food and Drug Administration (FDA) to treat non-small cell lung cancer with these particular mutations, after capmatinib.[10]

Medical uses

Tepotinib is

non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping.[4][5]

Adverse effects

The most common side effects seen in clinical trials were edema, fatigue, nausea, diarrhea, muscle aches, and

toxic to a developing fetus.[5] The most common treatment-related adverse effect in a 2021 study were peripheral edema (54.1%), nausea (20.0%), diarrhea (19.6%), blood creatinine increased (17.6%), and hypoalbuminemia (14.5%), which were 'mostly mild or moderate'.[11]

Society and culture

Legal status

In December 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Tepmetko, intended for the treatment of people with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping.[12] The applicant for this medicinal product is Merck Europe.[12] Tepotinib (Tepmetko) was approved for medical use in the European Union in February 2022.[6][7]

The US Food and Drug Administration (FDA) granted the application for tepotinib orphan drug designation.[13] In February 2024, the FDA converted the approval of tepotinib for adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations, to traditional approval.[14] It was previously granted accelerated approval for this indication in February 2021.[14] The application was granted breakthrough and orphan drug designations.[14]

References

  1. ^ a b "Tepmetko APMDS". Therapeutic Goods Administration (TGA). 27 January 2022. Retrieved 5 February 2022.
  2. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Retrieved 2 January 2023.
  3. ^ "Summary Basis of Decision (SBD) for Tepmetko". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  4. ^ a b c "Tepmetko- tepotinib hydrochloride tablet". DailyMed. Archived from the original on 27 November 2021. Retrieved 13 February 2021.
  5. ^ a b c d "FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer". Food and Drug Administration. 3 February 2021. Archived from the original on 3 February 2021. Retrieved 3 February 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ^ a b c "Tepmetko EPAR". European Medicines Agency (EMA). 14 December 2021. Archived from the original on 5 May 2022. Retrieved 5 May 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ^ a b "Tepmetko Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  8. ^ a b "FDA Approves Tepmetko as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations". EMD Serono (Press release). 3 February 2021. Archived from the original on 4 February 2021. Retrieved 3 February 2021.
  9. ^ "Tepmetko (Tepotinib) Approved in Japan for Advanced NSCLC with METex14 Skipping Alterations" (Press release). Merck KGaA. 25 March 2020. Retrieved 3 February 2021.
  10. S2CID 236915283
    .
  11. S2CID 237785148
    .
  12. ^ a b "Tepmetko: Pending EC decision". European Medicines Agency. 17 December 2021. Archived from the original on 18 December 2021. Retrieved 18 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  13. ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  14. ^ a b c "FDA approves tepotinib for metastatic non-small cell lung cancer". U.S. Food and Drug Administration (FDA). 15 February 2024. Retrieved 19 February 2024. Public Domain This article incorporates text from this source, which is in the public domain.

Further reading

External links
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