Rigel Pharmaceuticals Issues Dear Healthcare Provider Letter for GAVRETO® (pralsetinib)
SOUTH SAN FRANCISCO, Calif., Oct. 24, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. ("Rigel") (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced it is issuing a Dear Health Care Provider (DHCP) letter related to a new safety signal for GAVRETO(®) (pralsetinib) after consultation with the U.S. Food and Drug Administration (FDA). GAVRETO is for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by a FDA approved test and 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). The DHCP letter has been posted to the GAVRETO Healthcare Provider website at www.gavreto-hcp.com.
Patient safety is Rigel's highest priority. We are committed to ensuring healthcare providers are aware of this update.
Healthcare providers and patients are encouraged to report adverse events in patients taking GAVRETO to the Rigel Medical Communications Center at 1-800-983-1329 or producthelp@rigel.com. You may also report adverse events associated with taking GAVRETO directly to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).
Rigel announced the completion of the transfer to Rigel of the New Drug Application (NDA) for GAVRETO from Blueprint Medicines Corporation in June 2024.
About GAVRETO(®) (pralsetinib)
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 fusion-positive thyroid cancer who require systemic
therapy and who are radioactive iodine-refractory (if radioactive iodine
is appropriate)*
*This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
IMPORTANT SAFETY INFORMATION
-- Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening,
and fatal ILD/pneumonitis can occur in patients treated with GAVRETO.
Pneumonitis occurred in 12% of patients who received GAVRETO, including
3.3% with Grade 3-4, and 0.2% 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 35% of patients, including Grade 3
hypertension in 18% of patients. Overall, 8% had their dose interrupted
and 4.8% 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 1.5% of
patients treated with GAVRETO. Increased aspartate aminotransferase
(AST) occurred in 49% of patients, including Grade 3 or 4 in 7% and
increased alanine aminotransferase (ALT) occurred in 37% of patients,
including Grade 3 or 4 in 4.8%. The median time to first onset for
increased AST was 15 days (range: 5 days to 2.5 years) and increased ALT
was 24 days (range: 7 days to 3.7 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.
-- Hemorrhagic Events: Serious, including fatal, hemorrhagic events can
occur with GAVRETO. Grade >=3 events occurred in 4.1% 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.
-- Risk of Impaired Wound Healing: 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.
-- Embryo-Fetal Toxicity: 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
last dose. Advise males with female partners of reproductive potential
to use effective contraception during treatment with GAVRETO and for 1
week after the last dose.
-- Common adverse reactions (>=25%) were musculoskeletal pain,
constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and
cough. Common Grade 3/4 laboratory abnormalities (>=2%) were decreased
lymphocytes, decreased neutrophils, decreased hemoglobin, decreased
phosphate, decreased leukocytes, decreased sodium, increased aspartate
aminotransferase (AST), increased alanine aminotransferase (ALT),
decreased calcium (corrected), decreased platelets, increased alkaline
phosphatase, increased potassium, decreased potassium, and increased
bilirubin.
-- Avoid coadministration of GAVRETO with strong or moderate CYP3A
inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate
CYP3A inhibitors. If coadministration cannot be avoided, reduce the
GAVRETO dose. Avoid coadministration of GAVRETO with strong or moderate
CYP3A inducers. If coadministration cannot be avoided, increase the
GAVRETO dose.
-- Lactation: Advise women not to breastfeed during treatment with GAVRETO
and for 1 week after the last dose.
-- Pediatric Use: Monitor open growth plates in adolescent patients.
Consider interrupting or discontinuing GAVRETO if abnormalities occur.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here to see the full Prescribing Information and Patient Information for GAVRETO.
GAVRETO is a registered trademark of Rigel Pharmaceuticals, Inc.
About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit www.rigel.com.
Forward Looking Statements
This press release contains forward-looking statements relating to, among other things, safety signal and warnings and precautions regarding the use of GAVRETO (pralsetinib) and has direct reference to a dear doctor letter which further discusses ad hoc analysis from the AcceleRET-Lung trial and corresponding updates to the product label. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "forthcoming," "potential", "may", "expects", "will" and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of GAVRETO; risks that the FDA or other regulatory authorities may make adverse decisions regarding GAVRETO; risks that GAVRETO may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop market and distribute GAVRETO; risks related to the transition of GAVRETO to Rigel, including risks related to the effectiveness of transition services and drug continuity; market competition for GAVRETO; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.
Contact for Investors & Media:
Investors:
Rigel Pharmaceuticals, Inc.
650.624.1232
ir@rigel.com
Media:
David Rosen
Argot Partners
646.461.6387
david.rosen@argotpartners.com
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SOURCE Rigel Pharmaceuticals, Inc.
