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Tecvayli

BLA 761291, held by Janssen Biotech. Teclistamab-Cqyv.

  • First approved: Oct 25, 2022
  • Review: Priority
  • Supplements approved: 11
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below
DateSubmissionStatusDocuments
Mar 5, 2026Supplement 18Efficacy (new indication or use) · Priority reviewApprovedLabelLetterMedication Guide
Nov 22, 2024Supplement 9Efficacy (new indication or use) · Standard reviewApprovedLetter
Feb 20, 2024Supplement 3Efficacy (new indication or use) · Standard reviewApprovedLetterLabel
Oct 25, 2022Original applicationNew molecular entity · Priority reviewApprovedReviewLetterLabel

Products

2 strengths and forms
ProductActive ingredientMarketing
Tecvayli30MG/3ML(10MG/ML) · injectable;injectionTeclistamab-CqyvRx
Tecvayli153MG/1.7ML(90MG/ML) · injectable;injectionTeclistamab-CqyvRx
All 12 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
May 6, 2026Supplement 17REMSApprovedLetter
Mar 5, 2026Supplement 18Efficacy (new indication or use) · Priority reviewApprovedLabelLetterMedication Guide
Oct 2, 2025Supplement 15REMSApprovedLetter
Aug 19, 2025Supplement 13Labeling · Standard reviewApprovedLabelLetter
Dec 2, 2024Supplement 11REMSApprovedLetter
Nov 22, 2024Supplement 9Efficacy (new indication or use) · Standard reviewApprovedLetter
Jul 2, 2024Supplement 7REMSApprovedNone posted
May 28, 2024Supplement 8Labeling · Standard reviewApprovedLabelLetter
Feb 20, 2024Supplement 3Efficacy (new indication or use) · Standard reviewApprovedLetterLabel
Nov 16, 2023Supplement 5REMSApprovedLetter
Aug 9, 2023Supplement 4REMSApprovedREMSLetterLabel
Oct 25, 2022Original applicationNew molecular entity · Priority reviewApprovedReviewLetterLabel

Identifiers

Application
BLA 761291

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

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