Eisai Co., Ltd. to Present Latest Data on Lenvima® At the 2020 Gastrointestinal Cancers Symposium
January 22, 2020 at 03:57 am IST
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Eisai Co., Ltd. announced the presentation of three abstracts
at the 2020 Gastrointestinal Cancers Symposium (#GI20) in San Francisco from January 23-25. This release discusses investigational uses for FDA-approved products. It is not intended to convey conclusions
about efficacy and safety. There is no guarantee that any investigational uses of FDA-approved products will
successfully complete clinical development or gain FDA approval. For the treatment of patients with locally recurrent or metastatic, progressive, radioactive
iodine-refractory differentiated thyroid cancer (RAI-refractory DTC). In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC)
following one prior anti-angiogenic therapy. For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma that is
not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease
progression following prior systemic therapy, and are not candidates for curative surgery or radiation.
This indication is approved under accelerated approval based on tumor response rate and durability of
response. Continued approval for this indication may be contingent upon verification and description of
clinical benefit in the confirmatory trial. Warnings and Precautions
Hypertension. In DTC, hypertension occurred in 73% of patients on LENVIMA (44% grade 3-4). In RCC, hypertension
occurred in 42% of patients on LENVIMA + everolimus (13% grade 3). Systolic blood pressure =160 mmHg occurred
in 29% of patients, and 21% had diastolic blood pressure =100 mmHg. In HCC, hypertension occurred in 45% of
LENVIMA-treated patients (24% grade 3). Grade 4 hypertension was not reported in HCC. Serious complications of poorly controlled hypertension have been reported. Control blood pressure prior to
initiation. Monitor blood pressure after 1 week, then every 2 weeks for the first 2 months, and then at least
monthly thereafter during treatment. Withhold and resume at reduced dose when hypertension is controlled or
permanently discontinue based on severity. Cardiac Dysfunction. Serious and fatal cardiac dysfunction can occur with LENVIMA. Across clinical trials in
799 patients with DTC, RCC, and HCC, grade 3 or higher cardiac dysfunction occurred in 3% of LENVIMA treated
patients. Monitor for clinical symptoms or signs of cardiac dysfunction. Withhold and resume at reduced dose
upon recovery or permanently discontinue based on severity Arterial Thromboembolic Events. Among patients receiving LENVIMA or LENVIMA + everolimus, arterial
thromboembolic events of any severity occurred in 2% of patients in RCC and HCC and 5% in DTC. Grade 3-5
arterial thromboembolic events ranged from 2% to 3% across all clinical trials. Permanently discontinue
following an arterial thrombotic event. The safety of resuming after an arterial thromboembolic event has not
been established and LENVIMA has not been studied in patients who have had an arterial thromboembolic event
within the previous 6 months. Hepatotoxicity. Across clinical studies enrolling 1,327 LENVIMA-treated patients with malignancies other than
HCC, serious hepatic adverse reactions occurred in 1.4% of patients. Fatal events, including hepatic failure,
acute hepatitis and hepatorenal syndrome, occurred in 0.5% of patients. In HCC, hepatic encephalopathy occurred
in 8% of LENVIMA-treated patients (5% grade 3-5). Grade 3-5 hepatic failure occurred in 3% of LENVIMA-treated
patients. 2% of patients discontinued LENVIMA due to hepatic encephalopathy and 1% discontinued due to hepatic
failure. Monitor liver function prior to initiation, then every 2 weeks for the first 2 months, and at least monthly
thereafter during treatment. Monitor patients with HCC closely for signs of hepatic failure, including hepatic
encephalopathy. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity. Renal Failure or Impairment. Serious including fatal renal failure or impairment can occur with LENVIMA. Renal
impairment was reported in 14% and 7% of LENVIMA-treated patients in DTC and HCC, respectively. Grade 3-5 renal
failure or impairment occurred in 3% of patients with DTC and 2% of patients with HCC, including 1 fatal event
in each study. In RCC, renal impairment or renal failu re was reported in 18% of LENVIMA + everolimus "treated
patients (10% grade 3). Proteinuria. In DTC and HCC, proteinuria was reported in 34% and 26% of LENVIMA-treated patients, respectively.
Grade 3 proteinuria occurred in 11% and 6% in DTC and HCC, respectively. In RCC, proteinuria occurred in 31% of
patients receiving LENVIMA + everolimus (8% grade 3). Monitor for proteinuria prior to initiation and
periodically during treatment. If urine dipstick proteinuria =2+ is detected, obtain a 24-hour urine protein.
Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity. Diarrhea. Of the 737 LENVIMA-treated patients in DTC and HCC, diarrhea occurred in 49% (6% grade 3). In RCC,
diarrhea occurred in 81% of LENVIMA + everolimus "treated patients (19% grade 3). Diarrhea was the most frequent
cause of dose interruption/reduction, and diarrhea recurred despite dose reduction. Promptly initiate
management of diarrhea. Withhold and resume at reduced dose upon recovery or permanently discontinue based on
severity. Fistula Formation and Gastrointestinal Perforation. Of the 799 patients treated with LENVIMA or LENVIMA +
everolimus in DTC, RCC, and HCC, fistula or gastrointestinal perforation occurred in 2%. Permanently
discontinue in patients who develop gastrointestinal perforation of any severity or grade 3-4 fistula. Hypocalcemia. In DTC, grade 3-4 hypocalcemia occurred in 9% of LENVIMA-treated patients. In 65% of cases,
hypocalcemia improved or resolved following calcium supplementation with or without dose interruption or dose
reduction. In RCC, grade 3-4 hypocalcemia occurred in 6% of LENVIMA + everolimus " treated patients. In HCC,
grade 3 hypocalcemia occurred in 0.8% of LENVIMA-treated patients. Monitor blood calcium levels at least
monthly and replace calcium as necessary during treatment. Withhold and resume at reduced dose upon recovery or
permanently discontinue depending on severity. Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction. LENVIMA impairs exogenous thyroid
suppression.
Eisai Company specializes in the manufacturing and marketing of pharmaceutical products. Net sales break down by family of products as follows:
- pharmaceutical products (87.7%): prescribed drugs, health products, etc.;
- other (12.3%): food additives, chemical products, etc.
Net sales are distributed geographically as follows: Japan (46.2%), Europe (19.5%), Americas (15.5%), China (10.3%) and other (8.4%).