Taiho Pharmaceutical Obtains Approval of Additional Dosage and Administration for Breast Cancer in Japan for Antitumor Agent ABRAXANEF I.V. Infusion 100 mg

Taiho Pharmaceutical Co., Ltd. announced today that an antitumor agent "ABRAXANE® I.V. Infusion 100 mg" (paclitaxel protein-bound particles for injectable suspension (albumin-bound); [nab-paclitaxel]), launched in Japan in September 2010, received additional approval for weekly administration*1 in combination with atezolizumab (genetic recombinant) in patients with breast cancer from Japan's Ministry of Health, Labour and Welfare.

ABRAXANE was approved in Japan to treat patients with breast cancer in July 2010, gastric cancer and non-small cell lung cancer in February 2013 and unresectable pancreatic cancer in December 2014. The additional dosage and administration in the breast cancer indication was approved on the basis of a global phase III clinical study (IMpassion130 study) conducted by Chugai Pharmaceutical Co., Ltd. and is in addition to the already approved course of administration every three weeks*2.

The IMpassion130 study is a Phase III, multicentre, double-blind, randomized, placebo-controlled, global clinical study evaluating the efficacy, safety, and pharmacokinetics of atezolizumab in combination with ABRAXANE compared with ABRAXANE plus placebo in patients with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer. One of the primary endpoints of this study is progression-free survival (PFS) in the intent-to-treat (ITT) and PD-L1 positive population, statistically significant extension of PFS was shown.*3

ABRAXANE, is albumin-bound nanoparticles of paclitaxel that can be reconstituted with saline solution. It was developed by Abraxis BioScience, LLC and is marketed worldwide by Celgene Corporation, the parent company of Abraxis BioScience, LLC. Taiho Pharmaceutical has the development and marketing rights in Japan. ABRAXANE was initially approved in January 2005 by the U.S. FDA for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. As of January 2019, it has been approved in 74 countries worldwide, including the U.S. and Europe.

In Japan, 86,500 women (2018 predicted value) are estimated to be afflicted with breast cancer each year, and 14,800 women in Japan (2018 predicted value) die as a result of the disease.*4 Triple-negative breast cancer is defined by the lack of expression of female hormone receptors (estrogen and progesterone receptors) and the overexpression of the HER2 protein and amplification of the HER2 gene, which are involved in cancer cell proliferation. Triple-negative breast cancer accounts for 15% of all breast cancer cases and generally progresses quickly and carries a poor prognosis.

Product Name
ABRAXANE® I.V. Infusion 100 mg (paclitaxel injection [suspension with albumin])

Indication
Breast cancer, gastric cancer, non-small cell lung cancer and unresectable pancreatic cancer

Dosage and Administration (Newly approved dosage and administration is underlined.)
Either method A or method E*5 should be used for breast cancer; either method A or method D should be used for gastric cancer; method B should be used for non-small cell lung cancer; and method C used for unresectable pancreatic cancer.

Method A: In usual cases, paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 260 mg/m2 (body surface area), followed by a treatment-free interval for at least 20 days.

The treatment cycle above is to be repeated.

Dosage should be reduced based on the patient's condition.

Method B: In usual cases, paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 100 mg/m2 (body surface area), followed by a treatment-free interval for at least 6 days. The administration is once a week for 3 consecutive weeks, repeating this cycle subsequently. Dosage should be reduced based on the patient's condition.

Method C: In usual cases, in combination with gemcitabine, paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 125 mg/m2 (body surface area), followed by a treatment-free interval for at least 6 days. The administration is once a week for 3 consecutive weeks followed by a one-week rest. The treatment cycle above is to be repeated. Dosage should be reduced based on the patient's condition.

Method D: In usual cases, paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 100 mg/m2 (body surface area), followed by a treatment-free interval for at least 6 days. The administration is once a week for 3 consecutive weeks followed by a one-week rest. The treatment cycle above is to be repeated. Dosage should be reduced based on the patient's condition.

Method E: In usual cases, in combination with atezolizumab (genetic recombinant), paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 100 mg/m2 (body surface area), followed by a treatment-free interval for at least 6 days. The administration is once a week for 3 consecutive weeks followed by a one-week rest. The treatment cycle above is to be repeated. Dosage should be reduced based on the patient's condition.

*1. Administration once per week is continued for a period of 3 weeks after which there is a treatment-free interval of 1 week, which constitutes a single course. This course may be repeated.

*2. There is a treatment-free interval of at least 20 days after each administration, which constitutes a single course. This course may be repeated.

*3: Source: Schmid P, Adams S, Rugo HS, et al. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer. N Engl J Med 2018;379:2108-21

*4. "Latest Cancer Statistics," a cancer information service of the National Cancer Center Japan

https://ganjoho.jp/reg_stat/statistics/stat/index.html.

*5. A usage and dosage limited to "PD-L1-positive, hormone receptor-negative and HER2-negative inoperable or metastatic breast cancer" which is the indication for atezolizumab

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