GAVRETO will be available from Rigel in the
U.S. beginning June 27, 2024
SOUTH
SAN FRANCISCO, Calif., June 24,
2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc.
("Rigel") (Nasdaq: RIGL) today announced the completion of the
transfer to Rigel of the New Drug Application (NDA) for
GAVRETO® (pralsetinib) for the treatment of adult
patients with metastatic rearranged during transfection (RET)
fusion-positive non-small cell lung cancer (NSCLC) as detected by a
U.S. Food and Drug Administration (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). GAVRETO will be commercially available from
Rigel in the U.S. by prescription beginning June 27, 2024.
"The transfer of U.S. rights to GAVRETO has been completed and
we are excited to announce that GAVRETO – a once-daily, oral
targeted therapy for patients with RET fusion-positive mNSCLC and
advanced thyroid cancer – will be available to patients from Rigel
beginning this week. Our distributors, patient services, and field
teams are ready and committed to ensuring both existing and new
patients and providers can have access to this important treatment
option without interruption," said Raul
Rodriguez, Rigel's president and CEO. "The addition of
GAVRETO to our commercial portfolio is another important step
forward in our strategy to leverage our existing infrastructure and
expertise to expand our hematology and oncology business."
GAVRETO's NSCLC indication is fully approved by the FDA and its
advanced thyroid indication is approved under accelerated approval
based on overall response rate and duration of response. Continued
approval for the advanced thyroid indication may be contingent upon
verification and description of clinical benefit in confirmatory
trial(s). Discussions with the FDA regarding confirmatory
requirements are ongoing.
GAVRETO is the only once daily, oral RET-inhibitor therapy that
is designed to selectively target RET in mNSCLC and advanced or
metastatic thyroid carcinoma. The recommended dosage of GAVRETO is
400 mg taken orally once daily. GAVRETO will be supplied as
follows:
NDC
Number
|
Capsule
Strength
|
Package
Configuration
|
WAC
Price
|
71332-006-60
|
100 mg
|
Bottles of 60
capsules
|
$11,144.58
|
71332-006-90
|
100 mg
|
Bottles of 90
capsules
|
$16,716.85
|
For those who qualify, Rigel offers patient assistance programs
for patients prescribed GAVRETO by their doctor. RIGEL
ONECARE®, the company's comprehensive patient support
center, can help patients and physicians as they navigate through
insurance coverage requirements and provide financial assistance
when needed and if eligible, along with other support programs. To
learn more, visit www.RIGELONECARE.com or contact RIGEL
ONECARE at 833-RIGELOC (833-744-3562).
Rigel announced its acquisition of the U.S. commercial
rights of GAVRETO from Blueprint Medicines Corporation in
February 2024.
About NSCLC
It is estimated that over 230,000 adults
in the U.S. will be diagnosed with lung cancer in 2024. Lung
cancer is the leading cause of cancer death in the U.S, with NSCLC
being the most common type accounting for 80-85% of all lung cancer
diagnoses.1 RET fusions are implicated in
approximately 1-2% of patients with NSCLC.2
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 and RIGEL ONECARE are registered trademarks 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.
- The American Cancer Society. Key Statistics for Lung Cancer.
Revised January 29, 2024. Accessed
June 10, 2024:
https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html
- Kato, S. et al. RET aberrations in diverse cancers:
next-generation sequencing of 4,871 patients. Clin Cancer Res. 2017 April 15;23(8):1988-1997.
doi: 10.1158/1078-0432.CCR-16-1679
Forward Looking Statements
This press release
contains forward-looking statements relating to, among other
things, the potential benefits of Rigel's acquisition of U.S.
rights to GAVRETO, including opportunities in NSCLC and DTC,
Rigel's ability to leverage its existing commercial infrastructure
to market and distribute GAVRETO, provide patients with access to
GAVRETO, and the market opportunity for GAVRETO. 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
"plan", "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 March 31,
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
212.600.1902
david.rosen@argotpartners.com
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SOURCE Rigel Pharmaceuticals, Inc.