Zegfrovy (sunvozertinib) is filed as EGFR exon 20 insertion kinase inhibitor. The sections below restate public label fields stored for this profile.
To treat locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations with disease progression on or after platinum-based chemotherapy
12.1 Mechanism of Action Sunvozertinib is a kinase inhibitor of the epidermal growth factor receptor (EGFR) that binds to and inhibits EGFR exon 20 insertion mutations at similar concentrations as wild-type EGFR. In cultured cell models, sunvozertinib inhibited EGFR phosphorylation in cells expressing different EGFR exon 20 insertion mutation variants at approximately 2- to 10-fold lower concentrations than wild-type EGFR signaling inhibition. Sunvozertinib exhibited anti-tumor activity against xenograft models of NSCLC with EGFR exon 20 insertion mutations.
5. WARNINGS AND PRECAUTIONS Interstitial Lung Disease (ILD)/Pneumonitis : Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold ZEGFROVY in patients with suspected ILD/pneumonitis and permanently discontinue ZEGFROVY if ILD/pneumonitis is confirmed. ( 2.3 , 5.1 ) Gastrointestinal Adverse Reactions : Administer ZEGFROVY with food to reduce gastrointestinal adverse reactions. Monitor patients for nausea, vomiting and diarrhea and provide supportive care, including anti-diarrheals, anti-emetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. ( 2.3 , 5.2 ) Dermatologic Adverse Reactions : Monitor patients for rash and dermatologic adverse reactions. Instruct patients to use alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream during treatment with ZEGFROVY and to avoid the use of irritating skin products (e.g., products containing retinol or retinoic acid, benzoyl peroxides). Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. ( 2.3 , 5.3 ) Ocular Toxicity: Promptly refer patients presenting with eye symptoms suggestive of keratitis to an ophthalmologist. Advise discontinuation of contact lenses until ocular symptoms are evaluated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. ( 2.3 , 5.4 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective non-hormonal contraception. ( 5.5 , 8.1 , 8.3 ) 5.1 Interstitial Lung Disease/Pneumonitis ZEGFROVY can cause severe and life-threatening interstitial lung disease (ILD)/pneumonitis. In the safety population [see Adverse Reactions (6.1) ] , ILD/pneumonitis occurred in 1.7% of patients. The median time to first onset for ILD/pneumonitis was 61 days (range: 35 to 86 days). ZEGFROVY was discontinued due to ILD/pneumonitis in 0.8% of patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, and fever). Immediately withhold ZEGFROVY in patients with suspected ILD/pneumonitis and permanently discontinue ZEGFROVY if ILD/pneumonitis is confirmed [see Dosage and Administration (2.3) ] . 5.2 Gastrointestinal Adverse Reactions ZEGFROVY can cause severe gastrointestinal adverse reactions including diarrhea, nausea, and vomiting. In the safety population [see Adverse Reactions (6.1) ], serious gastrointestinal adverse reactions occurred in 1.7% of patients, including 0.8% Grade 3 nausea. Diarrhea occurred in 73% of patients who received ZEGFROVY, including 2.5% Grade 3. Diarrhea leading to dosage interruption or dose reduction occurred in 5% of patients and required permanent discontinuation of ZEGFROVY in 0.8% of patients. Nausea and vomiting occurred in 43% of patients, including 3.3% Grade 3 events. Nausea and vomiting leading to dosage interruption or dose reduction occurred in 7% of patients and permanent discontinuation of ZEGFROVY in 0.8% of patients. Administer ZEGFROVY with food to reduce gastrointestinal adverse reactions . Monitor patients for gastrointestinal toxicity, and provide supportive care, including anti-diarrheals, anti-emetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity [see Dosage and Administration (2.3) ] . 5.3 Dermatologic Adverse Reactions ZEGFROVY can cause severe rash including acneiform dermatitis and pruritus. Based on the safety population [see Adverse Reactions (6.1) ] , dermatologic adverse reactions occurred in 68% of patients including 9% acneiform dermatitis. Grade 3 dermatologic adverse reactions were 7% rash, 0.8% acneiform dermatitis, and 0.8% pruritus. Instruct patients to use alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream during treatment with ZEGFROVY and to avoid the use of irritating skin products (e.g., products containing retinol or retinoic acid, benzoyl peroxides). Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity [see Dosage and Administration (2.3) ]. 5.4 Ocular Toxicity ZEGFROVY can cause ocular toxicity including keratitis, dry eye symptoms, blurred vision, and visual impairment. Based on the safety population [see Adverse Reactions (6.1) ], ocular toxicity occurred in 13% of patients who received ZEGFROVY, including keratitis (0.8%). Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Advise discontinuation of contact lenses until ocular symptoms are evaluated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity [see Dosage and Administration (2.3) ]. 5.5 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, ZEGFROVY can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of sunvozertinib to pregnant animals during the period of organogenesis resulted in structural abnormalities at concentrations below the human exposure at the recommended dose based on area under the curve (AUC) [see Use in Specific Populations (8.1) ] . Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose, since ZEGFROVY can render some hormonal contraceptives ineffective [see Drug Interactions (7.2) ] . Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZEGFROVY and for 2 weeks after the last dose [see Use in Specific Populations (8.1 , 8.3) ] .
4. CONTRAINDICATIONS None. None. ( 4 )
Diarrhea (≥20%); Rash (≥20%); Decreased appetite (≥20%); Stomatitis (≥20%); Fatigue (≥20%); Nausea (≥20%); Paronychia (≥20%); Vomiting (≥20%); Constipation (≥20%); Musculoskeletal pain (≥20%); Pruritus (≥20%); Dry skin (≥20%); Urinary tract infection (≥20%); Abdominal pain (≥20%); Decreased weight (≥20%)
6. ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.1) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.2) ] Dermatologic Adverse Reactions [see Warnings and Precautions (5.3) ] Ocular Toxicity [see Warnings and Precautions (5.4) ] The most common (≥20%) adverse reactions were: diarrhea, rash, decreased appetite, stomatitis, fatigue, nausea, paronychia, vomiting, constipation, musculoskeletal pain, pruritus, dry skin, urinary tract infection, abdominal pain and decreased weight. ( 6.1 ) The most common (≥2%) Grade 3 or 4 laboratory abnormalities were: decreased lymphocytes, increased lipase, decreased hemoglobin, increased amylase, increased creatine kinase, decreased neutrophils, decreased potassium, increased aspartate aminotransferase, increased alanine aminotransferase, decreased sodium, increased magnesium, and increased alkaline phosphatase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dizal Pharmaceutical Co., Ltd. at +1-855-482-0653 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety populations described in WARNINGS AND PRECAUTIONS reflect exposure to ZEGFROVY as a single agent at a dose of 200 mg orally once daily in 121 patients with locally advanced or metastatic NSCLC from two clinical trials WU-KONG1 (NCT03974022) [see Clinical Studies (14) ] and WU-KONG2 (n=3). Among 121 patients who received ZEGFROVY, 56% were exposed for 6 months or longer and 28% were exposed for greater than one year. In this pooled safety population, the most common (≥20%) adverse reactions were diarrhea, rash, decreased appetite, stomatitis, fatigue, nausea, paronychia, vomiting, constipation, musculoskeletal pain, pruritus, dry skin, urinary tract infection, abdominal pain and decreased weight. The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, increased lipase, decreased hemoglobin, increased amylase, increased creatine kinase, decreased neutrophils, decreased potassium, increased aspartate aminotransferase, increased alanine aminotransferase, decreased sodium, increased magnesium, and increased alkaline phosphatase. EGFR Exon 20 Insertion Mutation-Positive Locally Advanced or Metastatic NSCLC Previously Treated with Platinum-Based Chemotherapy The safety of ZEGFROVY was evaluated in WU-KONG1B [see Clinical Studies (14) ] in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations in a multinational, open-label, dose randomization clinical trial. Eligible patients must have had disease progression on or after platinum-based chemotherapy and received ZEGFROVY 200 mg orally once daily until disease progression or intolerable toxicity. The median age of patients who received ZEGFROVY was 62 years (range: 35-88); 67% were females; 65% were Asian and 33% were White; 97% were not of Hispanic or Latino ethnicity. Serious adverse reactions occurred in 41% of patients who received ZEGFROVY. Serious adverse reactions in ≥2% of patients who received ZEGFROVY were pneumonia (9%); dyspnea (4.4%); and pancreatitis, device related infection and rash (2.2% each). Fatal adverse reactions occurred in 2.2% of patients who received ZEGFROVY including thrombosis (1.1%) and COVID-19 infection (1.1%). Permanent discontinuation of ZEGFROVY due to adverse reactions occurred in 8% of patients. Adverse reactions leading to treatment discontinuation of ZEGFROVY in ≥2% of patients were pneumonia and rash (2.2% each). Dosage interruption of ZEGFROVY due to adverse reactions occurred in 48% of patients. Adverse reactions requiring dosage interruption of ZEGFROVY in ≥5% of patients were vomiting (9%), pneumonia (8%), and rash (8%). Dose reduction of ZEGFROVY due to adverse reactions occurred in 23% of patients. Adverse reactions requiring dose reduction of ZEGFROVY in ≥3% of patients were rash (4.4%) and diarrhea (3.3%). Table 2 summarizes the adverse reactions in WU-KONG1B. Table 2: Adverse Reactions (≥10%) in Patients with Locally Advanced or Metastatic NSCLC Who Received ZEGFROVY in WU-KONG1B Adverse Reaction ZEGFROVY N=91 All grades NCI CTCAE v5.0. (%) Grade 3 or 4 (%) Gastrointestinal disorders Diarrhea Grouped Terms 73 2.2 Stomatitis 40 2.2 Vomiting 35 0 Nausea 32 2.2 Constipation 27 0 Weight decreased 26 3.3 Abdominal pain 19 1.1 Abdominal distension 16 0 Skin and subcutaneous tissue disorders Rash 60 8 Paronychia 30 0 Pruritus 26 1.1 Dry skin 21 0 Metabolism and nutrition disorders Decreased appetite 52 0 General disorders and administration site conditions Fatigue 41 1.1 Edema 11 0 Malaise 11 1.1 Musculoskeletal and connective tissue disorders Musculoskeletal pain 26 2.2 Infections and infestations Urinary tract infection 24 1.1 Pneumonia 25 11 Eye disorders Ocular toxicity 18 0 Nervous system disorders Peripheral neuropathy 14 0 Cardiac disorders Arrhythmia 12 1.1 Clinically relevant adverse reactions in <10% of patients who received ZEGFROVY were: cough, dizziness, dyspnea, dry eye and keratitis. Table 3 summarizes the laboratory abnormalities in WU-KONG1B. Table 3: Selected Laboratory Abnormalities (≥20%) That Worsened from Baseline in Patients with Locally Advanced or Metastatic NSCLC Who Received ZEGFROVY in WU-KONG1B Laboratory Abnormality ZEGFROVY N=91 The denominator used to calculate the rate varied from 89 to 90 based on the number of patients with a baseline and at least one post-treatment value. All Grades NCI CTCAE v5.0 (%) Grade 3 or 4 (%) Chemistry Creatinine increased 62 0 Creatine kinase increased 57 8 Lipase increased 47 13 Aspartate aminotransferase increased 44 4.4 Amylase increased 37 9 Sodium decreased 33 3.4 Albumin decreased 32 0 Potassium decreased 29 3.4 Alanine aminotransferase increased 28 4.4 Magnesium increased 23 4.4 Alkaline phosphatase increased 21 2.2 Hematology Hemoglobin decreased 61 12 Lymphocytes decreased 54 20 Neutrophils decreased 41 4.4 Urinalysis Urine protein increased 38 0 Other Clinical Trials Experience The following adverse reactions occurred following administration of ZEGFROVY: Interstitial Lung Disease (ILD)/Pneumonitis
2. DOSAGE AND ADMINISTRATION Recommended dosage: 200 mg orally once daily taken with food. ( 2.2 ) 2.1 Patient Selection Select patients for treatment with ZEGFROVY for locally advanced or metastatic NSCLC based on the presence of EGFR exon 20 insertion mutations in tumor tissue [see Clinical Studies (14) ] . Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage The recommended dosage of ZEGFROVY is 200 mg orally once daily with food [see Warnings and Precautions (5.2) ] until disease progression or unacceptable toxicity. Swallow ZEGFROVY tablets whole. Do not split, crush, chew, or dissolve the tablets. Take ZEGFROVY at the same time each day. Missed Dose If a dose of ZEGFROVY is missed within 12 hours, take the dose. If a dose of ZEGFROVY is missed by more than 12 hours, skip the missed dose and take the next dose at the regularly scheduled time. Vomiting If a ZEGFROVY dose is vomited, do not take an additional dose. Take the next dose at the regularly scheduled time. 2.3 Dosage Modifications for Adverse Reactions Reduce the dose of ZEGFROVY to 150 mg orally once daily with food, for the management of adverse reactions. Permanently discontinue ZEGFROVY in patients unable to tolerate 150 mg orally once daily. The recommended dosage modifications for adverse reactions are provided in Table 1. Table 1: Recommended Dosage Modifications of ZEGFROVY for Adverse Reactions Adverse Reaction Severity Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0). Dose Modifications Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.1) ] Any Grade Withhold ZEGFROVY if ILD/pneumonitis is suspected. Permanently discontinue ZEGFROVY if ILD/pneumonitis is confirmed. Nausea or Vomiting [see Warnings and Precautions (5.2) ] Grade 1 Administer supportive care including anti-emetics. Grade 2 Administer supportive care including anti-emetics. Withhold ZEGFROVY until recovery to Grade ≤1; then resume ZEGFROVY at the same dose. Grade 3 or 4 Administer supportive care including anti-emetics. Withhold ZEGFROVY until recovery to Grade ≤1; then resume ZEGFROVY at the next lower dose. Diarrhea [see Warnings and Precautions (5.2) ] Grade 1 Administer supportive care including anti-diarrheals (i.e., loperamide). Grade 2 or 3 First occurrence Administer supportive care and anti-diarrheals (i.e., loperamide). Withhold ZEGFROVY until recovery to Grade ≤1; then resume ZEGFROVY at the same dose level. Recurrence Withhold ZEGFROVY until recovery to Grade ≤1; then resume ZEGFROVY at the next lower dose. Grade 4 First occurrence Withhold ZEGFROVY and provide supportive care and anti-diarrheals (i.e., loperamide). If resolved to Grade ≤1 within 3 weeks, resume ZEGFROVY at the next lower dose. If not resolved to Grade ≤1 within 3 weeks, permanently discontinue ZEGFROVY. Recurrence Permanently discontinue ZEGFROVY. Dermatologic Adverse Reactions [see Warnings and Precautions (5.3) ] Grade 2 Administer supportive care. Reassess within 3 weeks, if rash does not improve, consider ZEGFROVY dose reduction. Grade 3 Withhold ZEGFROVY and administer supportive care. Upon recovery to Grade ≤1, resume ZEGFROVY at the next lower dose. If no improvement within 3 weeks, permanently discontinue ZEGFROVY. Grade 4 Permanently discontinue ZEGFROVY. Ocular Toxicity [see Warnings and Precautions (5.4) ] Any Grade Withhold ZEGFROVY if ulcerative keratitis is suspected. Permanently discontinue ZEGFROVY if ulcerative keratitis is confirmed. Other Adverse Reactions [see Adverse Reaction (6.1) ] Grade 3 or 4 Withhold ZEGFROVY. If resolved to Grade ≤1 within 3 weeks, resume ZEGFROVY at the same dose or the next lower dose. If not resolved to Grade ≤1 within 3 weeks, permanently discontinue ZEGFROVY. 2.4 Dosage Modifications for Drug Interactions Strong CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce the ZEGFROVY dose from 200 mg to 150 mg [see Drug Interactions (7.1) ] . After discontinuing a CYP3A inhibitor, resume the ZEGFROVY dose (after 3 to 5 half-lives of the CYP3A inhibitor) that was taken prior to initiating the CYP3A inhibitor. Strong and Moderate CYP3A Inducers Avoid concomitant use of strong and moderate CYP3A inducers . If concomitant use cannot be avoided, increase the ZEGFROVY dose from 200 mg to 400 mg [see Drug Interactions (7.1) ]. After discontinuing a CYP3A inducer, resume the ZEGFROVY dose (7 to 14 days after discontinuing the CYP3A inducer) that was taken prior to initiating the CYP3A inducer.
7. DRUG INTERACTIONS Strong CYP3A Inhibitors : Avoid concomitant use. If concomitant use cannot be avoided, reduce ZEGFROVY dose. ( 2.4 , 7.1 ) Strong and Moderate CYP3A Inducers : Avoid concomitant use. If concomitant use cannot be avoided, increase ZEGFROVY dose. ( 2.4 , 7.1 ) P-gp or BCRP Substrates : Monitor for increased adverse reactions during concomitant use with ZEGFROVY. ( 7.2 ) Hormonal Contraceptives : Avoid concomitant use. ( 7.2 ) 7.1 Effect of Other Drugs on ZEGFROVY Table 4 describes drug interactions where coadministration with another drug affects ZEGFROVY. Table 4: Effect of Other Drugs on ZEGFROVY Strong CYP3A Inhibitors Prevention or Management Avoid concomitant use with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce ZEGFROVY dose as recommended [see Dosage and Administration (2.4) ] and monitor for increased ZEGFROVY adverse reactions. Mechanism and Clinical Effect(s) Sunvozertinib is a CYP3A substrate. Concomitant use with strong CYP3A inhibitors increases sunvozertinib exposure [see Clinical Pharmacology (12.3) ], which may increase the risk of ZEGFROVY-associated adverse reactions. Strong or Moderate CYP3A Inducers Prevention or Management Avoid concomitant use with strong and moderate CYP3A inducers. If concomitant use cannot be avoided, increase ZEGFROVY dose as recommended [see Dosage and Administration (2.4) ]. Mechanism and Clinical Effect(s) Sunvozertinib is a CYP3A substrate. Concomitant use with strong or moderate CYP3A inducers decreases sunvozertinib exposure [see Clinical Pharmacology (12.3) ], which may reduce effectiveness of ZEGFROVY. 7.2 Effect of ZEGFROVY on Other Drugs Table 5 describes drug interactions where coadministration with ZEGFROVY affects another drug. Table 5: Effect of ZEGFROVY on Other Drugs Hormonal Contraceptives (CYP3A Substrates) Prevention or Management Avoid concomitant use of ZEGFROVY with hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose. Mechanism and Clinical Effect(s) Sunvozertinib is an inducer of CYP3A4. Concomitant use of ZEGFROVY with CYP3A substrates decreased their plasma concentrations [see Clinical Pharmacology (12.3) ] , where minimal concentration changes may lead to therapeutic failure of hormonal contraceptives. P-gp or BCRP Substrates Prevention or Management Monitor for increased adverse reactions of P-gp or BCRP substrates, where minimal concentration changes may lead to serious adverse reactions, when coadministered with ZEGFROVY. Mechanism and Clinical Effect(s) Sunvozertinib is an inhibitor of P-gp and BCRP. ZEGFROVY increases exposure of P-gp or BCRP substrates [see Clinical Pharmacology (12.3) ], which may increase the risk of adverse reactions associated with these substrates.
17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Interstitial Lung Disease/Pneumonitis Advise patients that ZEGFROVY can cause interstitial lung disease/pneumonitis. Advise patients to immediately contact their healthcare provider for new or worsening respiratory symptoms [see Warnings and Precautions (5.1) ]. Gastrointestinal Toxicity Advise patients that ZEGFROVY can cause gastrointestinal toxicity, including nausea, vomiting, and diarrhea. Advise patients to take ZEGFROVY with food to reduce gastrointestinal adverse reactions. Advise patients to immediately contact their healthcare provider for symptoms of gastrointestinal toxicity [see Warnings and Precautions (5.2) ]. Dermatologic Adverse Reactions Advise patients that ZEGFROVY can cause dermatologic adverse reactions, including rash and pruritus. Advise patients to use alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream during treatment with ZEGFROVY and to avoid the use of irritating skin products (e.g., products containing retinol or retinoic acid, benzoyl peroxides). Advise patients to immediately contact their healthcare provider for symptoms of dermatologic adverse reactions [see Warnings and Precautions (5.3) ]. Ocular Toxicity Advise patients that ZEGFROVY can cause ocular toxicity. Advise patients to contact their healthcare provider if they develop eye symptoms. Advise discontinuation of contact lenses until symptoms are evaluated [see Warnings and Precautions (5.4) ] and at least one week after symptoms have resolved . Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.5) , Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose [see Use in Specific Populations (8.3) ], since ZEGFROVY can render some hormonal contraceptives ineffective [see Drug Interactions (7.2) ] . Advise males with female partners of reproductive potential to use effective contraception during treatment with ZEGFROVY and for 2 weeks after the last dose [see Use in Specific Populations (8.3) ] . Lactation Advise women not to breastfeed during treatment with ZEGFROVY and for 2 weeks after the last dose [see Use in Specific Populations (8.2) ] . Infertility Advise females and males of reproductive potential that ZEGFROVY may impair fertility [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1) ] . Drug Interactions Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7.1 , 7.2) ].
According to its FDA label, Zegfrovy (sunvozertinib) is approved for: To treat locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations with disease progression on or after platinum-based chemotherapy For medical advice, please talk to your prescriber or pharmacist.
Zegfrovy (sunvozertinib) belongs to the EGFR exon 20 insertion kinase inhibitor class of medications.
The FDA label lists Zegfrovy (sunvozertinib) as: 3. DOSAGE FORMS AND STRENGTHS Tablets: 150 mg: yellow, biconvex film-coated tablets, debossed with "150" on one side and Dizal company logo on the other side. 200 mg: yellow, biconvex film-coated tablets, debossed with "200" on one side and Dizal company logo on the other side. Tablets: 150 mg and 200 mg. ( 3 ); oral route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Zegfrovy. Availability changes as patents expire.
Our ingest of the FDA label for Zegfrovy (sunvozertinib) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Zegfrovy (sunvozertinib) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Zegfrovy (sunvozertinib) as 2025-07-02.
The FDA label lists Dizal Pharmaceutical Co., Ltd. as a labeler/manufacturer of Zegfrovy (sunvozertinib). Multiple firms may market generics of the same molecule.
The FDA label states: "16. HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZEGFROVY tablets are supplied in bottles with a child-resistant cap as follows: Tablet Strength Description Quantity NDC Code 150 mg Yellow, biconvex film-coated tablets…" Follow the packaging insert for the authoritative guidance.
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