Rigel announces post-hoc analysis of data from TAVALISSE® in adult patients with immune thrombocytopenia published in the British Journal of Hematology
SOUTH SAN FRANCISCO, California, July 27, 2020 / PRNewswire / – Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that an article presenting a post-hoc analysis of data from TAVALISSE® (fostamatinib disodium hexahydrate), along with the accompanying commentary have been published in the British Journal of Haematology. TAVALISSE, Rigel’s oral spleen tyrosine kinase (SYK) inhibitor, is indicated for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an inadequate response to previous therapy.
“This post-hoc data analysis represents a potential paradigm shift in the treatment of adult patients with ITP following the use of first-line therapy, primarily steroids,” said Ralph boccia, MD, Center for Cancer and Blood Disorders, Bethesda, Maryland and first author of the article. “ITP is a heterogeneous disease that requires an individualized therapeutic approach. This data analysis provides clinicians with a better understanding of the role of TAVALISSE, with its novel mechanism of action, as an alternative treatment at the onset of the disease. “
Rigel conducted the previously presented post hoc data analysis of a phase 3 clinical program of TAVALISSE in adult patients with ITP. Analysis of the published data and accompanying comments highlight the higher response rate and decreased bleeding events in ITP patients receiving TAVALISSE as second-line therapy. In this analysis, 32 patients received second-line fostamatinib, of which 78% (25/32) achieved at least 1 platelet count of at least 50,000 / µL during treatment (without rescue therapy). Adverse events were manageable and consistent with those previously reported with fostamatinib.
In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP include fatigue, excessive bruising, and bleeding. People with chronic ITP may live with an increased risk of serious bleeding events that can lead to serious medical complications or even death. In addition to fostamatinib, current therapies for ITP include steroids, blood platelet production boosters (TPO-RA), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.
TAVALISSE® (fostamatinib disodium hexahydrate) tablets are indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous therapy.
Important safety information
Warnings and precautions
- High blood pressure can occur with treatment with TAVALISSE. Patients with pre-existing hypertension may be more sensitive to hypertensive effects. Monitor blood pressure every 2 weeks until it stabilizes, then monthly, and adjust or initiate antihypertensive therapy to maintain blood pressure control during treatment. If the increase in blood pressure persists, interruption, reduction or discontinuation of TAVALISSE may be necessary.
- Elevated liver function tests (LFTs), mainly ALT and AST, may occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or ASAT increases to> 3x upper limit of normal, manage hepatotoxicity by using interruption, reduction or discontinuation of TAVALISSE.
- Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures soon after symptom onset. If the diarrhea becomes severe (≥ grade 3), interrupt, reduce the dose or stop TAVALISSE.
- Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with interruption, reduction or discontinuation of TAVALISSE.
- TAVALISSE may harm the unborn child when given to pregnant women. Inform pregnant women of the potential risk to the fetus. Advise women of childbearing potential to use effective contraception during treatment and for at least 1 month after the last dose. Check pregnancy before starting TAVALISSE. It is not known if TAVALISSE or its metabolite is present in human milk. Due to the risk of serious side effects in a nursing child, a nursing woman is advised not to breast-feed while taking TAVALISSE and for at least 1 month after the last dose.
- Concomitant use of TAVALISSE with strong inhibitors of CYP3A4 increases exposure to the main active metabolite of TAVALISSE (R406), which may increase the risk of side effects. Monitor for toxicities which may necessitate a reduction in the dose of TAVALISSE.
- It is not recommended to use TAVALISSE with strong inducers of CYP3A4, as concomitant use reduces exposure to R406.
- Concomitant use of TAVALISSE may increase the concentrations of certain CYP3A4 substrate drugs and may require a reduction in the dose of the CYP3A4 substrate drug.
- Concomitant use of TAVALISSE may increase the concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a reduction in the dose of the substrate drug BCRP and P-gp.
- Serious adverse drug reactions in the double-blind ITP studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, occurring in 1% of TAVALISSE patients. In addition, serious side effects occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope and hypoxia (all 1% ).
- Common side effects (≥ 5% and more frequent than placebo) of FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, increased ALT and AST, respiratory infection, rash, abdominal pain, fatigue, chest pain and neutropenia.
Please watch www.TAVALISSE.com for complete prescribing information.
To report prescription drug side effects to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).
TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to the discovery, development and delivery of novel small molecule drugs that dramatically improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel’s pioneering research focuses on signaling pathways that are essential to disease mechanisms. The company’s first FDA-approved product is TAVALISSE® (fostamatinib disodium hexahydrate), the only oral inhibitor of spleen tyrosine kinase (SYK), for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to previous therapy. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients refractory to other treatments and is marketed in Europe under the name of TAVLESSE® (fostamatinib). Fostamatinib is currently under investigation in a researcher-sponsored trial led by Imperial College London for the treatment of COVID-19 pneumonia1.
Rigel’s clinical programs include a phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a phase 1 study completed on the R8351, a molecule that owns its interleukin receptor associated kinase inhibitor (IRAK) program; and an ongoing phase 1 study on the R5521, a molecule that owns its receptor-interacting protein kinase inhibitor (RIP) program. Additionally, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA and Daiichi Sankyo.
1The product for this use or indication is experimental and has not been proven safe or effective by a regulatory authority.
This press release contains forward-looking statements concerning, among other things, the potential benefit of using TAVALISSE in previous lines of therapy, including as second-line therapy, for adult patients with ITP. All statements contained in this press release that are not statements of historical fact can be considered as forward-looking statements. Words such as “potential”, “may”, “aim”, “believe”, “expect” and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements due to these risks and uncertainties, which include, without limitation, the risks and uncertainties associated with the marketing and marketing of TAVALISSE to United States and TAVLESSE in Europe; the risks of the FDA, the European Medicines Agency (EMA) or other regulatory authorities making adverse decisions regarding fostamatinib or any of Rigel’s product candidates; the risks that clinical trials may not be predictive of actual results or the results of subsequent clinical trials; the availability of resources to develop Rigel’s product candidates; competition in the market; as well as other risks detailed from time to time in Rigel’s reports filed with the Securities and Exchange Commission, including its annual report on Form 10-K for the financial year ended December 31, 2019 and its quarterly report on Form 10-Q for the quarter ended March 31, 2020. Additionally, the ongoing COVID-19 pandemic may cause further delays in Rigel’s studies and trials, or impact Rigel’s sales and its ability to source fostamatinib. Rigel assumes no obligation to update any forward-looking statements and expressly disclaims any obligation or commitment to publicly release any update or revision to any forward-looking statement contained herein.
IR Contact: David Burke
E-mail: [email protected]
SOURCE Rigel Pharmaceuticals, Inc.