Eribulin mesylate (Halaven, Eisai), an FDA approved drug for use in late stage breast cancer is now concurrently indicated for the treatment of soft-tissue sarcoma (STS) that is inoperable or has metastasized known as liposarcoma. Eribulin mesylate can now be used in patients who have previously received anthracycline chemotherapy as treatment for liposarcoma. Liposarcoma is difficult to treat; most patients tend to have resection of malignant cells or curative surgery. Tumor cells are removed during curative surgery but patients with advance disease state where STS has spread and surgery is not usually an option require radiation/chemotherapy. Eribulin mesylate showed clinically significant results for patients who are difficult to treat because they cannot be treated with surgery and have received previous treatment of chemotherapy (anthracycline) or the cancer has spread to other parts of the body.
According to the American Cancer Society and the National Program of Cancer Registries there are about 12,000 patients in the US annually diagnosed with STS-liposarcoma being one of the most common. 12,000 patient cases represent 1 % or less of newly diagnosed with malignant tumors, …show more content…
Incentives are provided via grants to aid in developing treatment for the heterogeneous disease states or conditions. Orphan drugs must still demonstrate promise for safe and effective treatment. However gaining orphan drug status acknowledges and identifies important drug development issues that can arise when trying to formulate a new drug. For example, drugs classified as orphan drugs are used in treatments of rare diseases therefore it is most likely not viable to test and develop this drug in 1,000 patients during a clinical trial because fewer patients than that may be harmed with the
According to the American Cancer Society and the National Program of Cancer Registries there are about 12,000 patients in the US annually diagnosed with STS-liposarcoma being one of the most common. 12,000 patient cases represent 1 % or less of newly diagnosed with malignant tumors, …show more content…
Incentives are provided via grants to aid in developing treatment for the heterogeneous disease states or conditions. Orphan drugs must still demonstrate promise for safe and effective treatment. However gaining orphan drug status acknowledges and identifies important drug development issues that can arise when trying to formulate a new drug. For example, drugs classified as orphan drugs are used in treatments of rare diseases therefore it is most likely not viable to test and develop this drug in 1,000 patients during a clinical trial because fewer patients than that may be harmed with the