FDA Greenlights Leuprolide Acetate Injection for Palliative Treatment in Advanced Prostate Cancer


The FDA has approved leuprolide acetate injection for use in the palliative treatment of patients with advanced prostate cancer.



The FDA has approved leuprolide acetate injection for use in the palliative treatment of patients with advanced prostate cancer.1,2

A synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone, leuprolide acetate has greater potency than the natural hormone.

"We are making tremendous progress expanding our injectables business," Harsher Singh, SVP for Amneal Biosciences, stated in a press release. "This latest new product is another key therapeutic for the institutional market and another complex, high value launch by the team."

Data from animal studies found that after an initial stimulation, continuous administration of the product led to suppression of ovarian and testicular steroidogenesis; this effect proved to be reversible upon treatment discontinuation.

Leuprolide acetate has been found to inhibit the growth of select hormone-dependent tumors, including prostatic tumors in Noble and Dunning male rats and DMBA-induced mammary tumors in female rats, as well as atrophy of the reproductive organs.

When leuprolide acetate was subcutaneously administered in single daily doses in humans, it led to an initial increase in circulating levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH); this resulted in a transient increase in gonadal steroids levels. However, continuous daily administration of the product led to decreased levels of LH and FSH.

In male patients, testosterone was reduced to castrate levels. Moreover, in female patients who were premenopausal, estrogens were reduced to post-menopausal levels. Notably, these decreases were noted to occur within 2 to 4 weeks following treatment initiation. Castrate levels of testosterone have been shown for periods of up to 5 years in patients with prostate cancer.

In a controlled study, investigators compared the use of subcutaneous leuprolide acetate given at 1 mg daily with that of diethylstilbestrol given at 3 mg daily. Survival rates were comparable in the groups 2 years of treatment. The objective response to treatment also proved to be similar between the groups.


  1. Amneal receives FDA approval for leuprolide acetate injection. News release. Amneal Pharmaceuticals, Inc. November 2, 2022. Accessed November 2, 2022. https://yhoo.it/3DusWZW
  2. Leuprolide acetate injection. Amneal Pharmaceuticals, Inc. Accessed November 2, 2022. https://bit.ly/3sQ1LDU
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