Comprehensive medication guide to Entrectinib including estimated pricing, availability information, side effects, and how to find it in stock at your local pharmacy.
Estimated Insurance Pricing
$0–$500 copay for commercially insured patients enrolled in Genentech's co-pay assistance program (up to $25,000/year). Without assistance, specialty tier cost-sharing can be thousands of dollars. Prior authorization required by virtually all plans.
Estimated Cash Pricing
$7,500–$8,500 per 28-day supply at retail specialty pharmacy prices for the brand-name Rozlytrek. There is no FDA-approved generic. No meaningful discounts are available through standard coupon programs for this specialty drug.
Medfinder Findability Score
65/100
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Entrectinib is an oral targeted cancer therapy sold under the brand name Rozlytrek, manufactured by Genentech (a Roche Group member). It was FDA-approved in August 2019 and belongs to the class of multikinase inhibitors. It is indicated for adults with ROS1-positive metastatic non-small cell lung cancer (NSCLC) and for adults and pediatric patients older than 1 month with NTRK gene fusion-positive solid tumors.
Entrectinib is a "tumor-agnostic" therapy for NTRK fusion cancers — meaning it can potentially treat many different cancer types (lung, breast, salivary gland, thyroid, colorectal, sarcoma, and others) as long as they carry an NTRK1/2/3 gene fusion, regardless of where the tumor originated.
Because entrectinib is a specialty medication with no generic available, it is only dispensed through specialty pharmacies and requires prior authorization from insurance. It is not available at regular retail pharmacies.
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Entrectinib is a selective tyrosine kinase inhibitor (TKI) that blocks three families of abnormal fusion proteins: TrkA, TrkB, and TrkC (encoded by NTRK1, NTRK2, and NTRK3 genes), the ROS1 oncogene, and the ALK kinase. These fusion proteins are created when cancer-associated gene rearrangements produce constantly active signaling molecules that drive tumor growth.
By binding to the ATP-binding pocket of these abnormal proteins at nanomolar concentrations, entrectinib blocks downstream signaling pathways that cause cancer cells to grow and survive. This phenomenon — where a tumor becomes entirely dependent on one aberrant kinase signal — is called "oncogene addiction," and it makes targeted TKI therapy highly effective for these specific cancers.
Entrectinib was specifically engineered to cross the blood-brain barrier, giving it CNS activity that older agents like crizotinib lack. This is a clinically important advantage for patients with ROS1-positive NSCLC, as CNS metastases occur in up to half of patients with this cancer type.
100 mg — capsule
Yellow hard-shell HPMC capsule for oral use
200 mg — capsule
Orange hard-shell HPMC capsule for oral use
50 mg — oral pellets
Film-coated pellets in packets; can be sprinkled on soft food — designed for pediatric patients and those who cannot swallow capsules
Entrectinib (Rozlytrek) is not listed on the FDA Drug Shortages Database as of 2026, meaning there is no manufacturing shortage. However, it is a specialty-only medication exclusively distributed through specialty pharmacy channels. It is not available at retail pharmacies, making access dependent on insurance plan networks, prior authorization approval, and financial assistance enrollment — all of which can take days to weeks for new patients.
Common access barriers include prior authorization delays, specialty pharmacy network mismatches, and financial assistance processing time. Patients who have an active PA and established specialty pharmacy relationship generally have few access problems.
If you're having difficulty locating a specialty pharmacy that can fill your prescription, medfinder contacts pharmacies near you to find out which ones can fill your Rozlytrek prescription, sending results to your phone by text.
Entrectinib is not a controlled substance and has no DEA scheduling requirements. However, it is an oncology specialty medication that most insurance plans require be prescribed by a physician specializing in oncology, or in consultation with one. Molecular biomarker testing confirming ROS1 gene rearrangement or NTRK gene fusion is required before prescribing.
Prescriber types who routinely prescribe entrectinib include:
Medical oncologists — the most common prescribers
Thoracic oncologists — specialists in lung cancers including ROS1-positive NSCLC
Pediatric oncologists — for pediatric NTRK fusion-positive solid tumors
Hematologist-oncologists — for hematologic cancers with NTRK fusions
Telehealth oncology consultations are available at many major cancer centers and can be used for follow-up management, but initial prescription of entrectinib typically requires in-person evaluation, tumor biopsy, and laboratory testing. Major academic cancer centers such as Memorial Sloan Kettering, MD Anderson, Mayo Clinic, and others offer remote second-opinion services for patients with rare biomarker-positive cancers.
No. Entrectinib (Rozlytrek) is not a DEA-scheduled controlled substance and has no addiction or abuse potential. It does not require special DEA registration to prescribe, and there are no federal restrictions on the number of refills or special prescription requirements related to controlled substance scheduling.
However, Rozlytrek is a prescription-only medication (Rx only) that requires a valid prescription from a licensed prescriber and prior authorization from most insurance plans. It must be dispensed through specialty pharmacies and requires biomarker confirmation (ROS1 or NTRK gene fusion test result) before initiation.
The following side effects occurred in 20% or more of patients in clinical trials:
Fatigue (48%)
Constipation (46%)
Dysgeusia / taste changes (44%)
Edema / swelling (40%)
Dizziness (38%)
Diarrhea (35%), Nausea (34%), Vomiting
Dysesthesia / abnormal sensations (34%)
Dyspnea / shortness of breath (30%)
Myalgia / muscle aches (28%), Arthralgia / joint pain
Cognitive impairment, weight gain, cough, fever
Congestive heart failure
CNS effects (hallucinations, severe confusion, loss of coordination)
Hepatotoxicity / liver damage (jaundice, dark urine)
Bone fractures (increased risk)
QT interval prolongation / heart rhythm abnormalities
Hyperuricemia / high uric acid (gout risk)
Vision disorders
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Larotrectinib (Vitrakvi)
Highly selective TRK inhibitor for NTRK fusion-positive solid tumors. FDA-approved 2018. Does not cover ROS1. Taken twice daily. Often considered to have more robust clinical data for NTRK cancers.
Repotrectinib (Augtyro)
Next-generation ROS1/TRK/ALK inhibitor. FDA-approved November 2023. Longest published median PFS for ROS1-positive NSCLC (31.1 months). More neurological side effects than entrectinib.
Crizotinib (Xalkori)
First-approved ROS1/ALK inhibitor. FDA-approved for ROS1-positive NSCLC 2016. Taken twice daily. Limited CNS penetration — not ideal for patients with brain metastases.
Taletrectinib (Ibtrozi)
Newer next-generation ROS1 TKI with impressive PFS data (median 49.6 months in TRUST-I). Increasingly used as first-line for ROS1-positive NSCLC.
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Strong CYP3A Inhibitors (itraconazole, ritonavir, clarithromycin)
majorIncrease entrectinib blood levels up to 6-fold. Avoid or reduce entrectinib dose if unavoidable.
Strong CYP3A Inducers (rifampin, carbamazepine, phenytoin, St. John's Wort)
majorDecrease entrectinib levels by up to 77%, potentially reducing efficacy. Avoid concomitant use.
QT-Prolonging Drugs (amiodarone, ondansetron/Zofran, levofloxacin)
majorAdditive QT prolongation risk increases risk of Torsade de Pointes. Avoid or monitor closely.
Grapefruit / Grapefruit Juice
majorContains CYP3A inhibitors that increase entrectinib exposure. Avoid all grapefruit products during treatment.
Moderate CYP3A Inhibitors (fluconazole, diltiazem, verapamil)
moderateIncrease entrectinib levels ~3-fold. Avoid or reduce dose if unavoidable.
Digoxin (P-gp substrate)
moderateEntrectinib increases digoxin Cmax by ~28% and AUC by 18%. Monitor digoxin levels.
Entrectinib (Rozlytrek) represents a significant advance in precision oncology — a once-daily oral pill that can treat a diverse range of cancers across many organ types by targeting the specific genetic driver of tumor growth. For patients with ROS1-positive NSCLC or NTRK fusion-positive solid tumors who confirm the right biomarker, it offers meaningful response rates and a drug designed to reach the brain.
Access challenges are real but largely navigable: prior authorization, specialty pharmacy routing, and financial assistance can all be managed through Genentech Access Solutions and your oncology team. The most important step is starting those conversations at the time of prescribing, not after problems arise.
If you're having difficulty locating a pharmacy that can fill your entrectinib prescription, medfinder is a paid service that contacts pharmacies near you on your behalf and texts you results — saving you the time and frustration of calling around yourself.
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Our medication guides are researched and written to help patients make informed decisions. All content is reviewed for accuracy and updated regularly. Learn more about our standards
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