For Patients

GAVRETO Safety

Lung Icon

GAVRETO was generally well tolerated in patients with RET+ mNSCLC1

mNSCLC=metastatic non–small cell lung cancer; RET+=rearranged during transfection positive.

Lung patient safety

Safety of GAVRETO was evaluated in 220 patients with RET+ mNSCLC in ARROW1

15%

of patients permanently discontinued GAVRETO
due to any adverse reaction1

6.4%

discontinued due to adverse reactions considered treatment-related by the trial investigator34

Adverse reactions resulting in permanent discontinuation which occurred in >1 patient included pneumonitis (1.8%), pneumonia (1.8%), and sepsis (1%).

Dose modifications and interruptions in RET fusion+ mNSCLC1

Dose reductions due to an adverse reaction occurred in 36% of patients treated with GAVRETO

Adverse reactions requiring dosage reductions in ≥2% of patients included neutropenia, anemia, pneumonitis, neutrophil count decreased, fatigue, hypertension, pneumonia, and leukopenia.

Dosage interruptions due to an adverse reaction occurred in 60% of patients treated with GAVRETO

Adverse reactions requiring dosage interruption in ≥2% of patients included neutropenia, pneumonitis, anemia, hypertension, pneumonia, pyrexia, increased aspartate aminotransferase (AST), increased blood creatine phosphokinase, fatigue, leukopenia, thrombocytopenia, vomiting, increased alanine aminotransferase (ALT), sepsis, and dyspnea.

Adverse reactions (≥15%) in RET fusion-positive mNSCLC patients who received GAVRETO in ARROW

Adverse Reactions GAVRETO (N=220)
Grades 1-4 (%) Grades 3-4 (%)
General
Fatigue* 35 2.3**
Pyrexia 20 0
Edema† 20 0
Gastrointestinal
Constipation 35 1**
Diarrhea‡ 24 3.2**
Dry Mouth 16 0
Musculoskeletal Disorders
Musculoskeletal Pain§ 32 0
Vascular
Hypertension|| 28 14**
Respiratory, thoracic, and mediastinal
Cough 23 0.5**
Infections
Pneumonia# 17 8

*Fatigue includes fatigue, asthenia.
†Edema includes edema peripheral, face edema, periorbital edema, eyelid edema, edema generalized, swelling.
‡Diarrhea includes diarrhea, colitis, enteritis.
§Musculoskeletal pain includes back pain, myalgia, arthralgia, pain in extremity, musculoskeletal pain, neck pain, musculoskeletal chest pain, bone pain, musculoskeletal stiffness, arthritis, spinal pain.
||Hypertension includes hypertension, blood pressure increased.
Cough includes cough, productive cough, upper-airway cough syndrome.
#Pneumonia includes pneumonia, atypical pneumonia, lung infection, pneumocystis jirovecii pneumonia, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia haemophilus, pneumonia influenza, pneumonia streptococcal.
**Only includes a Grade 3 adverse reaction.

Select laboratory abnormalities (≥20%) worsening from baseline in RET fusion-positive mNSCLC patients who received GAVRETO in ARROW

GAVRETO showed Grades 3-4 AST/ALT elevations of 2.3%

Laboratory Abnormality†† GAVRETO (N=220)
Grades 1-4 (%) Grades 3-4 (%)
Chemistry
Increased aspartate aminotransferase (AST) 74 2.3
Increased alanine aminotransferase (ALT) 49 2.3
Increased alkaline phosphatase 42 1.8
Decreased calcium (corrected) 39 1.8
Decreased albumin 36 0
Decreased phosphate 35 11
Increased creatinine 33 0.5
Decreased sodium 29 7
Increased potassium 26 0.9
Hematology
Decreased neutrophils 61 16
Decreased hemoglobin 58 9
Decreased lymphocytes 56 19
Decreased platelets 27 3.2

††Denominator for each laboratory parameter is based on the number of patients with a baseline and post-treatment laboratory value available, which ranged from 216 to 218 patients.
Clinically relevant laboratory abnormalities in <20% of patients who received GAVRETO included increased phosphate (10%).

Adverse reactions (≥15%) and Grades 3-4 laboratory abnormalities (≥2%) in RET fusion-positive mNSCLC patients within the exploratory follow-up analyses were generally consistent with the pivotal data included in the U.S. Prescribing Information (USPI)1,34
Recommended Dose Modifications
When should I modify dosage?

View the recommended dose reductions for GAVRETO for adverse reactions.

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NEXT: Important Safety Information

Important Safety Information & Indications

INDICATIONS

GAVRETO® (pralsetinib) is indicated for the treatment of:

  • Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

Interstitial Lung Disease (ILD)/Pneumonitis occurred in 10% of patients who received GAVRETO, including 2.7% with Grade 3/4, and 0.5% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD.

Hypertension occurred in 29% of patients, including Grade 3 hypertension in 14% of patients. Overall, 7% had their dose interrupted and 3.2% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.

Hepatotoxicity: Serious hepatic adverse reactions occurred in 2.1% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 69% of patients, including Grade 3/4 in 5% and increased alanine aminotransferase (ALT) occurred in 46% of patients, including Grade 3/4 in 6%. The median time to first onset for increased AST was 15 days (range: 5 days to 1.5 years) and increased ALT was 22 days (range: 7 days to 1.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity.

Grade ≥ 3 hemorrhagic events occurred in 2.5% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.

Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.

Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established.

Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the final dose. Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the final dose.

Common adverse reactions (≥25%) were constipation, hypertension, fatigue, musculoskeletal pain and diarrhea. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased calcium (corrected), decreased sodium, increased AST, increased ALT, decreased platelets and increased alkaline phosphatase.

Avoid coadministration of GAVRETO with strong CYP3A inhibitors or combined P-gp and strong CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please click here to see the full Prescribing Information for GAVRETO.

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