Augtyro

This indication is approved under accelerated approval based on overall response rate and duration of response

AUGTYRO is a kinase inhibitor indicated for the treatment of

• •adult patients with locally advanced or metastatic
  ROS1-
  positive non-small cell lung cancer (NSCLC). (
  1.1

  ROS1

  -Positive Non-Small Cell Lung Cancer

  AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic

  ROS1

  -positive non-small cell lung cancer (NSCLC)

  [see Dosage and Administration (2.1)]

  .
  )
• •adult and pediatric patients 12 years of age and older with solid tumors that:
• •have a neurotrophic tyrosine receptor kinase (
  NTRK
  ) gene fusion and
• •are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.
• •have progressed following treatment or have no satisfactory alternative therapy.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. (

• •Select patients for the treatment of locally advanced or metastatic NSCLC based on the presence of
  ROS1
  rearrangement(s) in tumor specimens. (
  2.1 Patient Selection

  NSCLC

  Select patients for the treatment of locally advanced or metastatic NSCLC with AUGTYRO based on the presence of

  ROS1

  rearrangement(s) in tumor specimens

  [see Clinical Studies (14.1)]

  . An FDA-approved test to detect

  ROS1

  rearrangements for selecting patients for treatment with AUGTYRO is not currently available.

  Solid Tumors

  Select patients for the treatment of solid tumors with AUGTYRO based on the presence of

  NTRK1/2/3

  rearrangements in tumor specimens

  [see Clinical Studies ]

  . An FDA-approved test to detect

  NTRK1/2/3

  rearrangements for selecting patients for treatment with AUGTYRO is not currently available.

  • •
    In patients with secretory breast cancer or mammary analogue secretory cancer, consider treatment without confirmation of

    NTRK

    rearrangements in tumor specimens.
  )
• •Select patients for treatment of locally advanced or metastatic solid tumors based on the presence of an NTRK gene fusion. (
  2.1 Patient Selection

  NSCLC

  Select patients for the treatment of locally advanced or metastatic NSCLC with AUGTYRO based on the presence of

  ROS1

  rearrangement(s) in tumor specimens

  [see Clinical Studies (14.1)]

  . An FDA-approved test to detect

  ROS1

  rearrangements for selecting patients for treatment with AUGTYRO is not currently available.

  Solid Tumors

  Select patients for the treatment of solid tumors with AUGTYRO based on the presence of

  NTRK1/2/3

  rearrangements in tumor specimens

  [see Clinical Studies ]

  . An FDA-approved test to detect

  NTRK1/2/3

  rearrangements for selecting patients for treatment with AUGTYRO is not currently available.

  • •
    In patients with secretory breast cancer or mammary analogue secretory cancer, consider treatment without confirmation of

    NTRK

    rearrangements in tumor specimens.
  )
• •
  Recommended Dosage
  : 160 mg orally once daily for 14 days, then increase to 160 mg twice daily, with or without food. (
  2.4 Recommended Dosage

  The recommended dosage of AUGTYRO for adult and pediatric patients 12 years of age and older is 160 mg taken orally once daily with or without food

  [see Clinical Pharmacology (12.3)]

  for 14 days, then increase to 160 mg twice daily and continue until disease progression or unacceptable toxicity.
  )

Capsules: 40 mg, white, opaque, immediate release, Size 0, hard shell capsule, filled with white to off-white powder which may appear as a plug, imprinted with “REP 40” in blue text on the cap.

Capsules: 160 mg, blue, opaque, immediate release, Size 0, hard shell capsule, filled with white to off-white powder which may appear as a plug, imprinted with “REP 160” in white text on the cap.

• •
  Lactation
  : Advise not to breastfeed. (
  8.2 Lactation

  Risk Summary

  There are no data on the presence of AUGTYRO in human milk or its effects on either the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children from AUGTYRO, advise a lactating woman to discontinue breastfeeding during treatment with AUGTYRO and for 10 days after the last dose.
  )