Entrectinib Shortage Update: What Patients Need to Know in 2026

If your oncologist recently prescribed Entrectinib (Rozlytrek) and you're struggling to fill it, you might be wondering if there's a shortage. The answer is nuanced: there is no active FDA-declared shortage of Rozlytrek in 2026, but patients regularly encounter access problems that are just as disruptive. Here's what you need to know.

Current Availability Status of Entrectinib in 2026

As of 2026, Rozlytrek (entrectinib) is NOT listed on the FDA Drug Shortages Database. This means Genentech, the manufacturer, is currently meeting the demand for the drug through its specialty pharmacy distribution network. There is no manufacturing shortage, no raw material shortage, and no FDA shortage designation.

However, the drug is only available through specialty pharmacies — not at retail drugstores. This means that "in stock" doesn't mean what it usually does. Even without a formal shortage, patients can face significant delays getting their prescription filled.

Why Do Entrectinib Access Problems Feel Like a Shortage?

The most common access barriers that patients report — and that can make it feel like a shortage — include:

Prior authorization delays: Most insurance plans require PA for Rozlytrek, including documented proof of biomarker testing (ROS1 or NTRK gene fusion). This process can take several days to several weeks.

Specialty pharmacy network restrictions: Your insurer may only cover Rozlytrek through one or two approved specialty pharmacies. If those pharmacies aren't in your area, the drug has to be shipped — adding time.

Financial assistance processing: Genentech's copay assistance program and patient assistance applications require paperwork, income verification, and time — especially for first-time patients.

PA renewal gaps: Prior authorizations for Rozlytrek are typically issued for 12 months. If a patient or their provider misses the renewal window, there can be a gap in supply.

Has Entrectinib Ever Been in a Shortage?

To our knowledge, the FDA has not formally declared Rozlytrek to be in a drug shortage since its approval in August 2019. As a specialty cancer medication with relatively low prescription volume (treating rare biomarker-positive cancers), it does not face the same manufacturing pressure as broadly used drugs. Its access challenges are structural, not due to manufacturing disruptions.

What Patients Should Do Right Now If They Can't Get Entrectinib

Contact Genentech Access Solutions immediately. Call 877-436-3683. They are the fastest path to resolving specialty pharmacy routing, prior authorization issues, and financial assistance for Rozlytrek.

Alert your oncology team. Your oncologist may be able to escalate the PA process, provide a bridge supply, or adjust the prescription to a covered specialty pharmacy.

Use medfinder to find pharmacies. medfinder calls pharmacies near you to find out which ones can fill your prescription, texting you the results.

Don't stop treatment without guidance. If there's going to be a gap in your supply, talk to your oncologist before stopping. They can advise on managing a brief interruption or consider a bridge option.

What If Entrectinib Goes Into a Formal Shortage in the Future?

If Rozlytrek were to enter a formal FDA shortage, Genentech would be required to notify the FDA and work to resolve it. In that scenario, your oncologist and specialty pharmacy would be notified and would help you navigate alternative sourcing or discuss transitioning to a comparable drug like larotrectinib (for NTRK) or repotrectinib/taletrectinib (for ROS1). The FDA Drug Shortages Database at accessdata.fda.gov is the most reliable place to check the latest status.

The Bottom Line

Entrectinib is not in shortage as of 2026. But if it feels like it is, that's because access to specialty cancer drugs is genuinely complex. See our guides on why entrectinib is hard to find and how to find it in stock near you for detailed next steps.