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 . 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 [email protected]. You may also report adverse events associated with taking GAVRETO directly to the FDA. Visit 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 . 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 . 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 [email protected] Media: David Rosen Argot Partners 646.461.6387 [email protected] SOURCE Rigel Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ST. LOUIS, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Optime Care, a nationally recognized specialty pharmacy and an AscellaHealth Company, today announces an expanded arrangement with Rigel Pharmaceuticals, Inc, effective October 14, 2024, to include commercial distribution of TAVALISSE® (fostamatinib). TAVALISSE is an oral medicine that can help patients manage chronic immune thrombocytopenia (ITP) by protecting their platelets from destruction. “Under this expanded agreement, Optime Care will now manage commercial distribution for three Rigel products: TAVALISSE, GAVRETO® (pralsetinib) and Rezlidhia® (olutasidenib),” says Stephanie Wasilewski, PharmD, general manager, Optime Care. “This new phase of our collaboration reflects Rigel Pharmaceuticals’ ongoing confidence in Optime Care’s ability to support highly specialized patient populations while optimizing patient outcomes. Our patient access and HUB services, including patient assistance programs (PAP), co-pay assistance and reimbursement support, are critical to delivering a high standard of care." Optime Care is recognized for its comprehensive patient support programs that integrate pre-commercialization expertise, distribution and national medication fulfillment. The company’s high-touch patient care model ensures seamless treatment transitions through high-touch patient support and HUB services designed to enhance patient outcomes. This collaboration marks another milestone in Optime Care’s ongoing mission to support patients with rare and complex diseases. “Optime Care continues to prove itself as a valuable partner in delivering our therapies to patients who need them most,” says Scott Yohe, VP, market access, Rigel Pharmaceuticals. “Their comprehensive approach to patient care and deep understanding of complex disease states make Optime Care a great choice to help us bring TAVALISSE, along with our other therapies, to patients nationwide. We look forward to continuing our successful collaboration.” Wasilewski notes that Rigel Pharmaceuticals selected Optime Care as a partner for the distribution of TAVALISSE based on our proven expertise in managing rare and chronic conditions, alongside a demonstrated ability to deliver superior patient support services. “Our services include patient intake, prescription fulfillment, prior authorization support and financial assistance programs,” she continues. “This collaboration underscores our ability to scale our support while maintaining the highest level of care for all patients.” Optime Care specialists excel in communication, optimizing the patient journey through personalized clinical guidance and ongoing support for patients and their families. Their deep understanding of complex, chronic diseases enhances patient access to essential therapies, streamlines care coordination and ensures that financial assistance is available for those who need it. About Optime CareOptime Care, Inc., an AscellaHealth Company, is a nationally recognized specialty pharmacy, distribution and patient management organization offering a suite of comprehensive services tailored to maximize therapeutic opportunities for the treatment of orphan and rare disorders. The executive team has partnered in the launch and management of over 40 orphan products and programs while consistently implementing the best brand services for the community. Optime Care has dual-accreditation from the Utilization Review Accreditation Commission (URAC) for compliance with specialty pharmacy and the Accreditation Commission for Health Care (ACHC) for specialty pharmacy services that demonstrate a commitment to providing quality care and services to consumers. Visit www.ascellahealth.com About RigelRigel 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. About TAVALISSE® TAVALISSE is a prescription medication used to treat adults with low platelet counts due to chronic immune thrombocytopenia (ITP) when a prior treatment for ITP has not worked well enough. It is not known if TAVALISSE is safe and effective in children. What is the most important information I should know about TAVALISSE? TAVALISSE can cause serious side effects including: High blood pressure (hypertension). New or worsening high blood pressure is common in people treated with TAVALISSE and can be severe. Your healthcare provider will check your blood pressure regularly during treatment with TAVALISSE. If needed, your healthcare provider may start you on blood pressure medicine or change your current medicine to treat your blood pressure. Tell your healthcare provider if you get headaches, confusion, dizziness, chest pain, or shortness of breath.Liver problems. Changes in liver function blood tests are common with TAVALISSE. Liver problems may occur and can be severe. Your healthcare provider will regularly do blood tests to check how well your liver is working during treatment with TAVALISSE.Diarrhea. Diarrhea is common in people treated with TAVALISSE and can be severe. Tell your healthcare provider if you get diarrhea during treatment with TAVALISSE. Your healthcare provider may recommend changes in your diet, drinking more water, or medicine to limit these symptoms.Decreases in white blood cell count (neutropenia). Decreases in your white blood cell count are common with TAVALISSE and can be severe. This may increase your risk for infection, including serious infections. Your healthcare provider will regularly do blood tests to check your white blood cell counts. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TAVALISSE if you have side effects. What do I need to discuss with my healthcare provider before taking TAVALISSE? Before you take TAVALISSE, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressurehave liver problemsare pregnant or plan to become pregnant. TAVALISSE can harm your unborn baby. Your healthcare provider will check if you are pregnant before starting treatment with TAVALISSE.Females who can become pregnant should use effective birth control during treatment with TAVALISSE and for at least 1 month after the last dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TAVALISSE with certain other medicines may affect how the other medicines work or how TAVALISSE works. What are the possible side effects of TAVALISSE? The most common side effects of TAVALISSE include: Nausea, rash, dizziness, tiredness, respiratory infection, chest pain, and stomach (abdomen) pain. These are not all the side effects of TAVALISSE. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA, at 1-800-FDA-1088. This press release was published by a CLEAR® Verified individual.