MIAMI and CHICAGO, April 27, 2026 /PRNewswire/ -- Xcovery Holdings, Inc., (Xcovery) an evidence-based, innovation-driven pharmaceutical company, today announced an agreement with EVERSANA®, a leading provider of commercialization services to the global life sciences industry, to support and expand the U.S. commercial launch of ENSACOVE™ (ensartinib), the company's novel therapy for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
Ensacove (ensartinib) is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals, Co. Ltd. (Betta). It is indicated for the treatment of adult patients with ALK-positive locally advanced or metastatic NSCLC as detected by an FDA-approved test who have not previously received an ALK inhibitor and is now available in the United States as a treatment for these patients (www.ensacove.com).
Under the agreement, EVERSANA will provide comprehensive end‑to‑end commercialization services for Xcovery, including but not limited to agency of record, market access, commercial and medical teams to support the company's strategy to make Ensacove available to more patients across the U.S.
"The approval of Ensartinib was a major milestone in our mission to advance precision oncology," said Giovanni Selvaggi, M.D., Chief Medical Officer of Xcovery Holdings, Inc. "As we expand the U.S. launch of ENSACOVE, we are focused on ensuring that patients and providers have the support they need. EVERSANA brings highly experienced, scalable commercialization capabilities, and we're pleased to partner with them to broaden patient access."
"EVERSANA was built to help companies just like Xcovery implement more impactful commercial strategies which will allow more patients to benefit from therapies like Ensartinib," said Gregory Skalicky, President, EVERSANA.
About ENSACOVE
ENSACOVE (ensartinib) is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.
ENSACOVE is contraindicated in patients who have experienced a severe hypersensitivity reaction to ENSACOVE, FD&C Yellow No. 5 (tartrazine), or to any of its components.
ENSACOVE can cause the following serious adverse reactions. Withhold, reduce the dose, or permanently discontinue ENSACOVE based on severity.
Interstitial Lung Disease (ILD)/Pneumonitis occurred in 5% of patients, including 1.3% Grade 3 and 0.4% Grade 4. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis and immediately withhold ENSACOVE if suspected. Permanently discontinue in patients with ILD/pneumonitis.
Hepatotoxicity, including drug-induced liver injury can occur. 59% of patients had increased alanine aminotransferase (ALT), including 5% Grade 3. Increased aspartate aminotransferase (AST) occurred in 58% of patients, including 1.8% Grade 3. Increased bilirubin occurred in 12% of patients, including 2.3% Grade 3 and 0.2% Grade 4. There was one case of drug-induced liver injury. Monitor liver function tests at baseline and every 2 weeks during the first cycle of treatment, and then monthly or as clinically indicated.
Dermatologic Adverse Reactions can occur, including drug reaction with eosinophilia and systemic symptoms (DRESS), rash, pruritus, and photosensitivity. Dermatologic adverse reactions occurred in 80% of patients, including Grade 3 in 14% of patients. Rash occurred in 72% of patients, including Grade 3 in 12% of patients. Pruritus occurred in 32% of patients, including 2.4% Grade 3. There was one Grade 3 case (0.2%) of DRESS. Advise patients to limit direct sun exposure during treatment and for at least 1 week after discontinuation. Monitor for dermatologic adverse reactions during treatment.
Bradycardia occurred in 6% of patients. All bradycardia events were Grade 1 or 2. Monitor heart rate regularly during treatment.
Hyperglycemia. Increased blood glucose occurred in 44% of patients, including Grade 3 in 2.5% (based on laboratory data). Monitor serum glucose periodically during treatment.
Visual Disturbances occurred in 8% of patients (0.2% Grade 3) and included blurred vision, diplopia, photopsia, vitreous floaters, visual impairment, visual field defect, and reduced visual acuity. Advise patients to report visual symptoms during treatment and obtain ophthalmologic evaluation in patients with visual disturbances.
Increased Creatine Phosphokinase (CPK) occurred in 43% of patients who had CPK laboratory data available, with Grade 3 in 1.5% and 0.5% Grade 4. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor CPK periodically during treatment.
Hyperuricemia occurred in 6% of patients, with 0.4% Grade 3 and 0.7% Grade 4. Monitor uric acid periodically during treatment and initiate urate-lowering medications as clinically indicated.
ENSACOVE can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception during treatment and for 1 week after the last dose.
ENSACOVE contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.
The most common adverse reactions (incidence ≥20%) were rash, musculoskeletal pain, constipation, pruritus, cough, nausea, edema, vomiting, fatigue, and pyrexia.
Drug Interactions: Avoid concomitant use of P-gp inhibitors and moderate or strong CYP3A inhibitors or inducers.
Lactation: Advise women not to breastfeed during treatment and for 1 week after the last dose.
Use in Specific Populations: Avoid use of ENSACOVE in patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).
Please see additional Important Safety Information in full Ensacove_Prescribing_Information.pdf
About Xcovery Holdings, Inc.
Xcovery Holdings, Inc. is an innovation‑driven pharmaceutical company focused on developing targeted oncology therapies that improve efficacy and tolerability for patients with advanced cancers. Learn more at www.xcovery.com.
About EVERSANA
EVERSANA® is a leading independent provider of global services to the life sciences industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X.
Media Contacts
For Xcovery
Jon Wan
Chief Executive Officer
For EVERSANA
Matt Braun
Vice President, Corporate Communications
[email protected]
SOURCE EVERSANA
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