Skip To Main Content
Lilly
Menu closed
Lilly
  • Account Login / Register
  • Medical Home
    • Medical Information
  • Medical Education
  • Science
Ask Lilly

We're here to help.

Chat
Chat with us Chat with us
Question Contact Us
Expand contact lilly
Lilly

You are now leaving the LillyMedical.com website

The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to LillyMedical.com.

  1. Medical Information Right
  2. Oncology Right
  3. Jaypirca (pirtobrutinib) tablets Right
  4. Is Jaypirca™ (pirtobrutinib) FDA approved?
Search Jaypirca (type in keywords)
Search Medical Information

If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)

Loading icon

Jaypirca ™ (pirtobrutinib) tablets

50 mg,100 mg

Full Prescribing Information

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

Is Jaypirca™ (pirtobrutinib) FDA approved?

Jaypirca (pirtobrutinib) is approved by the FDA for use in the United States for the treatment of adult patients with relapsed or refractory MCL after at least two lines of systemic therapy, including a BTK inhibitor.

US_cFAQ_PIR099_FDA_APPROVAL
US_cFAQ_PIR099_FDA_APPROVAL
en-US

Pirtobrutinib Approval in the United States

Pirtobrutinib was approved by United States Food and Drug Administration (FDA) for its use in the United States on January 27, 2023.

Pirtobrutinib is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.1

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

Enclosed Prescribing Information

JAYPIRCA™ (pirtobrutinib) tablets, for oral use, Lilly

Enclosed Patient Information

JAYPIRCA™ (pirtobrutinib) patient information, Lilly

Reference

1Jaypirca [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.

Date of Last Review: January 11, 2023

Are you satisfied with this content?

Can't find what you're looking for? Contact us for answers to your medical questions.

  • Copyright
  • Terms of Use
  • Privacy Statement
  • Accessibility Statement
  • Sitemap

    This site is intended for US Healthcare Professionals only.

    4.0.17 02/2023 | GLOOTH00001 04/2015 | © Lilly USA, LLC 2023. All rights reserved.

    Product names listed above are trademarks or registered trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates

    facebook twitter linkedin
    visit www.phactmi.org
    Lilly