Cary, N.C., July 1, 2025 – Effective July 1st, Bristol Myers Squibb Co. has reduced its specialty pharmacy network for AUGTYRO™ (repotrectinib) to a limited distribution network, including Biologics by McKesson, an independent specialty pharmacy specializing in oncology, rare and cell and gene therapy disease areas.
AUGTYRO is an FDA-approved kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). AUGTYRO is also used to treat 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, and have progressed following treatment or have no satisfactory alternative therapy.
ROS1-positive NSCLC is a rare form of lung cancer that occurs when the ROS1 gene fuses with part of another gene, causing uncontrolled cell growth. It’s generally found in the adenocarcinoma subtype of NSCLC. Patients with ROS1-positive NSCLC are often younger than the average lung cancer patient and frequently have little or no history of smoking. While NSCLC is the most common form of lung cancer, ROS1-positive accounts for approximately 1–2% of all lung cancer cases, according to the American Lung Association. ROS1-positive NSCLC can spread to the brain, making treatment challenging.
In solid tumors with an NTRK gene fusion, a piece of an NTRK gene, which is involved in neural development, fuses with an unrelated gene causing uncontrolled cell growth and cancer. NTRK gene fusions are rare in lung cancer, accounting for less than 1% of all lung cancer cases. According to the American Lung Association, no one type of patient demographic is more likely to have an NTRK gene fusion.
“Biologics by McKesson is honored to have been selected by Bristol Myers Squibb Co. as a specialty pharmacy within the new limited dispensing network for AUGTYRO,” says George Paschal, Sr. Director, Business Development, Biologics by McKesson. “Timely access to targeted therapies like AUGTYRO is crucial for improving response rates for NSCLC patients. Our deep expertise in cancer and rare diseases enables us to deliver high-touch clinical support that providers and patients can rely on throughout the treatment journey.”
Biologics by McKesson is committed to and recognized for its level of customer service as well as its innovative, high-touch, and multidisciplinary approach. Putting patients first in all they do, the Biologics pharmacy team includes pharmacists with in-depth knowledge of therapies, experienced nurses, and financial counselors who are familiar with various financial assistance programs and organizations that help patients.
For the full prescribing information for AUGTYRO, please click here. For more information about the treatment of patients with ROS1-positive or NTRK-positive NSCLC, please click here.
INDICATIONS
AUGTYRO® is indicated for the treatment of:
- Adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
- Adult and pediatric patients 12 years of age and older with solid tumors that:
- Have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion
- 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 trial(s).
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- Central Nervous System Adverse Reactions: Occurred in 77% of patients. Includes dizziness (65%), ataxia (28%), cognitive impairment (25%), mood disorders (6%), and sleep disorders (18%). Advise caution operating machinery.
- Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 3.1%. Monitor for pulmonary symptoms and discontinue if confirmed.
- Hepatotoxicity: Elevated ALT/AST levels. Monitor liver function regularly.
- Myalgia with CPK Elevation: Myalgia occurred in 13%, with elevated CPK in 3.7%. Monitor and manage accordingly.
- Hyperuricemia: Occurred in 5%. Monitor uric acid and treat with urate-lowering therapy as needed.
- Skeletal Fractures: Occurred in 2.3%. Monitor signs and symptoms. AUGTYRO is not approved for patients under 12 years old.
- Embryo-Fetal Toxicity: Can cause fetal harm. Use effective non-hormonal contraception.
Adverse Reactions
The most common adverse reactions (≥20%) were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, fatigue, ataxia, cognitive impairment, muscular weakness, and nausea.
Drug Interactions
- Effects of Other Drugs on AUGTYRO: Avoid use with P-gp inhibitors, CYP3A inducers/inhibitors.
- Effects of AUGTYRO on Other Drugs: Avoid with CYP3A4 substrates and hormonal contraceptives. May reduce effectiveness of other drugs.
Please see U.S. Full Prescribing Information for AUGTYRO.