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TAVALISSE delivered rapid, robust, and durable improvements in platelet counts

Response rates achieved in the 24-week evaluation period (double-blind, placebo-controlled trials)

Graph showing response rates of the TAVALISSE treatment group compared to placebo group

Median time to first response: 15 days4,‡

*Stable platelet response: achievement of a platelet count ≥50 x 109/L on ≥4 of the 6 visits during weeks 14-24 without need for rescue treatment.

Overall response: achievement of a platelet count ≥50 x 109/L at least once during the first 3 months/12 weeks without need for rescue treatment.

Time to first response was a post hoc analysis.

TAVALISSE DEMONSTRATED DURABLE BENEFIT BEYOND 3 YEARS

Overall response observations from a 3-year post hoc interim analysis3,§,||

Median Platelet Counts Over Time

§1 month = 4 weeks. Data cutoff date: March 8, 2018.

||Overall response: achievement of a platelet count ≥50 x 109/L at least once during the first 3 months/12 weeks without need for rescue treatment.

  • Patients were evaluated every 2 weeks in the placebo-controlled trials (FIT-1 + FIT-2) and no less often than monthly for 18 months, and then bimonthly for up to 5 years in the open-label extension study (FIT-3)2
  • A total of 102 patients exited the placebo-controlled trials early (at or after week 12) and entered the open-label extension study (FIT-3)1

RESPONSE TO TAVALISSE WAS SEEN IN PATIENTS ACROSS ALL LINES OF THERAPY

A post hoc analysis of the phase 3 clinical studies was conducted to evaluate patient response by line of therapy

Percentage of patients achieving target platelet counts at any visit

Time to response (platelet count ≥50 x 109/L) in responders to TAVALISSE5:

  • 56% of 2nd-line patients responded within 4 weeks
  • 76% of 2nd-line patients responded within 12 weeks
  • 81% of patients across all lines of therapy responded within 12 weeks

Data cutoff date: December 2019.

#Platelet response was assessed by the proportion of patients achieving platelet counts of ≥50 x 109/L and of ≥30 x 109/L at any visit (without rescue therapy within 4 weeks).

**Percentage of patients achieving platelet counts of ≥30 x 109/L calculated using data on file.3

This analysis measured the percentage of treatment days that patients maintained their response

Media Durability of Response

The majority of 2nd-line patients with platelet counts ≥50 x 109/L maintained their response for >36 months5

  • Rates of adverse events in these subgroups were consistent with those in patients treated with TAVALISSE in the placebo-controlled trials4,5

††Durability of response: median percentage of treatment days that patients maintained a response of ≥50 x 109/L or ≥30 x 109/L, with loss of response at the first of two platelet counts ≤30 x 109/L or ≤20 x 109/L, respectively, at least 4 weeks apart, or use of rescue therapy.

TAVALISSE demonstrated efficacy across patient subgroups compared to placebo

Treatment benefit favored TAVALISSE in the phase 3 clinical trials (FIT-1 + FIT-2)3

Graph showing TAVALISSE efficacy across patient subgroups

‡‡Post hoc subgroup.

TAVALISSE PATIENTS HAD FEWER BLEEDING EPISODES AND REQUIRED LESS RESCUE MEDICATION COMPARED TO PLACEBO

TAVALISSE patients had a lower incidence of bleeding episodes than placebo patients1,3

  • In the placebo-controlled trials, the incidence of bleeding in patients who received TAVALISSE (regardless of responder status) was 29%, compared with 37% in patients who received placebo

Graph comparing the incidence of bleeding among FIT trial participants

Of patients treated with TAVALISSE in the phase 3 clinical studies (FIT-1 + FIT-2 + FIT-3), 59% had no bleeding episodes.3,§§

TAVALISSE patients required less rescue medication than placebo patients4

  • In the placebo-controlled trials, 30% of patients who received TAVALISSE (regardless of responder status) required rescue medication, compared with 45% of patients who received placebo

Graph depicting the percentage of patients who required rescue medication during FIT trials

Of patients treated with TAVALISSE in the phase 3 clinical studies (FIT-1 + FIT-2 + FIT-3), 59% did not require rescue medication at any visit.3,§§

§§Compiled from interim analysis. Data cutoff: March 8, 2018.

References: 1. TAVALISSE® [package insert]. South San Francisco, CA: Rigel Pharmaceuticals, Inc.; April 2018. 2. Bussel JB, Arnold DM, Boxer MA, et al. Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program. Am J Hematol. 2019;94(5):546-553. 3. Data on file, Rigel Pharmaceuticals, Inc. April 2018. 4. Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: results of two phase 3, randomized, placebo-controlled trials. Am J Hematol. 2018;93(7):921-930. 5. Boccia R, Cooper N, Ghanima W, et al. Fostamatinib is an effective second-line therapy in patients with immune thrombocytopenia. Br J Haematol. 2020;190(6):933-938.

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Indication

TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information

Warnings and Precautions

  • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
  • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
  • 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 early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue 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 TAVALISSE interruption, reduction, or discontinuation.
  • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

Drug Interactions

  • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
  • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
  • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
  • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

Adverse Reactions

  • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
  • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

 

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Indication

TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information

Warnings and Precautions

  • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
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