On August 26, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that the anticancer agent TREAKISYM for Injection 100 mg (generic name: bendamustine hydrochloride, "TREAKISYM") has been approved in Japan for an additional indication of chronic lymphocytic leukemia (Press release, Eisai, AUG 26, 2016, View Source [SID:1234514752]). TREAKISYM is the subject of a licensing agreement concluded between Eisai and SymBio Pharmaceuticals Limited (Headquarters: Tokyo, President & CEO: Fuminori Yoshida, "SymBio").

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TREAKISYM was initially approved in Japan in October 2010 for relapsed or refractory low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma. Under the licensing agreement concluded between the two companies, Eisai has been marketing the product in Japan since its launch in December 2010.

Symbio filed an application for this additional indication in December 2015 in response to a development request from the Japanese Ministry of Health, Labour and Welfare’s Study Group on Unapproved and Off Label Drugs with high unmet medical needs. Chronic lymphocytic leukemia is a blood cancer characterized by neoplastic transformation and excess propagation of lymphocytes, a type of white blood cell, in the bone marrow. With approximately 2,000 patients with chronic lymphocytic leukemia in Japan as well as an incidence rate of new cases of approximately 0.3 in 100,000, this is a disease with high unmet medical need. Furthermore, TREAKISYM has been designated as an orphan drug for chronic lymphocytic leukemia in Japan.

Eisai positions oncology as a key therapeutic area and is aiming to discovery revolutionary new medicines with the potential to cure cancer. Eisai remains committed to maximizing the value of TREAKISYM as well as its in-house developed anticancer agents including Halaven and Lenvima, seeking to contribute further to addressing the diverse needs of patients with cancer and their families.

1. About bendamustine hydrochloride (generic name, product name: TREAKISYM)
Bendamustine hydrochloride is an anticancer agent originally synthesized by German (formerly ‘East German’) pharmaceutical company Jenapharm and is marketed in Europe under the brand names Ribomustin and Levact as a treatment for non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia. In the United States the product has been approved by the U.S. Food and Drug Administration and is currently marketed under the brand name TREANDA for the treatment of chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin’s lymphoma. Eisai concluded an exclusive licensing agreement with SymBio in August 2008 concerning the joint development and marketing of TREAKISYM in Japan, which was followed by a subsequent agreement between the two companies in May 2009 concerning the development and marketing of the agent in Singapore and South Korea.
2. About TREAKISYM (additional parts have been underlined)
Product Name:
TREAKISYM for Injection, for intravenous infusion 100 mg
Generic Name:
Bendamustine Hydrochloride
Indications and Usage:
1. For the treatment of relapsed or refractory forms of the following diseases:
Low-grade B-cell non-Hodgkin’s lymphoma
Mantle cell lymphoma
2. Chronic lymphocytic leukemia
Dosage and Administration:
1. For relapsed or refractory low-grade B-cell non-Hodgkin’s lymphoma or mantle cell lymphoma

The usual adult dose of bendamustine hydrochloride is 120 mg/m2 body surface area infused intravenously over 60 minutes on Days 1 and 2 of repeated 21-day cycles. The dose may be reduced appropriately according to the patient’s condition.
2. For chronic lymphocytic leukemia

The usual adult dose of bendamustine hydrochloride is 100 mg/m2 body surface area infused intravenously over 60 minutes on Days 1 and 2 of repeated 28-day cycles. The dose may be reduced appropriately according to the patient’s condition.

On August 26, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained a supplemental approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) on August 26, 2016, for the anti-cancer agent, capecitabine (brand name: Xeloda Tablets 300) for the indication of "adjuvant chemotherapy for rectal cancer (Press release, Chugai, AUG 26, 2016, View Source [SID:1234514751])." In Japan, Xeloda is currently on the market and its approved indications are "inoperable or recurrent breast cancer," "postoperative adjuvant chemotherapy for colon cancer," "advanced or refractory colorectal cancer, which is not amenable to curative resection" and "gastric cancer." With this supplemental approval, the indication of Xeloda has been changed to "colorectal cancer," covering the above indications for colon and colorectal cancer.

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"Xeloda in adjuvant chemotherapy for rectal cancer is regarded as the standard of care in several guidelines," said Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. "In addition to the current approved indications, this supplemental approval enables people with locally advanced rectal cancer to use Xeloda as well. We believe it will encourage patients to receive treatment with hope and positive thoughts."

The "26th Review Committee on Unapproved Drugs and Indications with High Medical Needs"* held on February 3, 2016, evaluated whether "public knowledge-based application" might be applicable for Xeloda in adjuvant chemotherapy for rectal cancer. On February 26, the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council made a decision that filing through the "public knowledge-based application" was reasonable. Given that decision, Chugai filed for Xeloda through a "public knowledge-based application" on March 2 and obtained this supplemental approval.

Xeloda was developed by Nippon Roche K.K. (currently Chugai) and has been approved in more than 100 countries worldwide. Chugai strongly believes that Xeloda will make a contribution to patients as a treatment option for "colorectal cancer." Chugai will continue its efforts to contribute to cancer treatment.

* The "Review Committee on Unapproved Drugs and Indications with High Medical Needs" was established for the purpose of enhancing development by the pharmaceutical companies of drugs and indications that have been approved for use in western countries but not yet approved in Japan, through activities such as evaluating medical needs and confirming the applicability of "public knowledge-based application" and investigating the need for studies that should be additionally conducted.

Xeloda is a registered trademark of F. Hoffmann-La Roche, Ltd. (Switzerland)

[Drug Information]

Brand name: Xeloda Tablets 300

Generic name: Capecitabine

Indications: Inoperable or recurrent breast cancer
Colorectal cancer
Gastric cancer

Dosage and administration:
Regimens A or B are available for the treatment of inoperable or recurrent breast cancer. Regimen B should be employed in adjuvant chemotherapy for colorectal cancer, while regimen C should be employed in combination with another anticancer agent for the treatment of advanced or recurrent colorectal cancer which is not amenable to curative resection. Regimen D should be employed in adjuvant chemotherapy for rectal cancer in combination with radiation therapy. Regimen C should be employed in combination with a platinum agent for the treatment of gastric cancer.

Regimen A:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 21 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Regimen B:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.33m2 1,500mg
≥1.33 to <1.57m2 1,800mg
≥1.57 to <1.81m2 2,100mg
≥1.81m2 2,400mg
Regimen C:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.36m2 1,200mg
≥1.36 to <1.66m2 1,500mg
≥1.66 to <1.96m2 1,800mg
≥1.96m2 2,100mg
Regimen D:
XELODA is administered orally in the following doses, ac-cording to body surface area, twice daily within 30 minutes after morning and evening meals for 5 consecutive days, followed by a 2-day rest period. This is repeated. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Drug price: JPY 360.2/TabletAugust 26, 2016 — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it obtained a supplemental approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) on August 26, 2016, for the anti-cancer agent, capecitabine (brand name: Xeloda Tablets 300) for the indication of "adjuvant chemotherapy for rectal cancer." In Japan, Xeloda is currently on the market and its approved indications are "inoperable or recurrent breast cancer," "postoperative adjuvant chemotherapy for colon cancer," "advanced or refractory colorectal cancer, which is not amenable to curative resection" and "gastric cancer." With this supplemental approval, the indication of Xeloda has been changed to "colorectal cancer," covering the above indications for colon and colorectal cancer.

"Xeloda in adjuvant chemotherapy for rectal cancer is regarded as the standard of care in several guidelines," said Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. "In addition to the current approved indications, this supplemental approval enables people with locally advanced rectal cancer to use Xeloda as well. We believe it will encourage patients to receive treatment with hope and positive thoughts."

The "26th Review Committee on Unapproved Drugs and Indications with High Medical Needs"* held on February 3, 2016, evaluated whether "public knowledge-based application" might be applicable for Xeloda in adjuvant chemotherapy for rectal cancer. On February 26, the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council made a decision that filing through the "public knowledge-based application" was reasonable. Given that decision, Chugai filed for Xeloda through a "public knowledge-based application" on March 2 and obtained this supplemental approval.

Xeloda was developed by Nippon Roche K.K. (currently Chugai) and has been approved in more than 100 countries worldwide. Chugai strongly believes that Xeloda will make a contribution to patients as a treatment option for "colorectal cancer." Chugai will continue its efforts to contribute to cancer treatment.

* The "Review Committee on Unapproved Drugs and Indications with High Medical Needs" was established for the purpose of enhancing development by the pharmaceutical companies of drugs and indications that have been approved for use in western countries but not yet approved in Japan, through activities such as evaluating medical needs and confirming the applicability of "public knowledge-based application" and investigating the need for studies that should be additionally conducted.

Xeloda is a registered trademark of F. Hoffmann-La Roche, Ltd. (Switzerland)

[Drug Information]

Brand name: Xeloda Tablets 300

Generic name: Capecitabine

Indications: Inoperable or recurrent breast cancer
Colorectal cancer
Gastric cancer

Dosage and administration:
Regimens A or B are available for the treatment of inoperable or recurrent breast cancer. Regimen B should be employed in adjuvant chemotherapy for colorectal cancer, while regimen C should be employed in combination with another anticancer agent for the treatment of advanced or recurrent colorectal cancer which is not amenable to curative resection. Regimen D should be employed in adjuvant chemotherapy for rectal cancer in combination with radiation therapy. Regimen C should be employed in combination with a platinum agent for the treatment of gastric cancer.

Regimen A:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 21 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Regimen B:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.33m2 1,500mg
≥1.33 to <1.57m2 1,800mg
≥1.57 to <1.81m2 2,100mg
≥1.81m2 2,400mg
Regimen C:
XELODA is administered orally in the following doses, according to body surface area, twice daily within 30 minutes after morning and evening meals for 14 consecutive days, followed by a 7-day rest period. The administration is repeated with this taken as one course. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.36m2 1,200mg
≥1.36 to <1.66m2 1,500mg
≥1.66 to <1.96m2 1,800mg
≥1.96m2 2,100mg
Regimen D:
XELODA is administered orally in the following doses, ac-cording to body surface area, twice daily within 30 minutes after morning and evening meals for 5 consecutive days, followed by a 2-day rest period. This is repeated. The dosage should be reduced according to the patient’s condition.
Body surface area Each dose
<1.31m2 900mg
≥1.31 to <1.64m2 1,200mg
≥1.64m2 1,500mg
Drug price: JPY 360.2/Tablet