Caposi Sarcoma (KS): The only oral, first new drug in 20 years, Andher's Squibb Pomalyst (Pomalyst) is approved by the United States!

May 16, 2020 /
PRNewswire
BIOON/-BMS, Inc., announced that the U.SFood and Drug Administration (
FDA) has approved Pomaliste (pomalidomide, Pomadodomide), a drug that has theactivity of anti-
tumorsImmunomodulators for the treatment of Patients with Kaposisarcoma (Kaposisarcoma, KS) specifically: (1) patients with HIV-related Kaposi sarcoma whose disease has become resistant to the highly effective antiretroviral drug (HAART) and (2) HIV-negative Patients with Kaposi sarcomait's worth noting that Pomalyst is the only oral and first new treatment approved for Caposi sarcoma (KS) for more than 20 yearsIt should be noted that patients with AIDS-related Caposi sarcoma should continue to use HAART for HIV treatment as recommended by their doctorPomalyst's treatment of the above-mentioned Caposi sarcoma indications has gainedFDAaccelerated approval, breakthrough drug eligibility (BTD), orphan drug eligibility (ODD)This accelerated approval is based on total mitigation rate (ORR) data for Phase I/II open label, single-armclinical trial(12-C-0047) Continued approval for these indications will depend on the validation and description of clinical benefits in validated trials Caposi sarcoma is a rare form of cancer that usually manifests itself as skin lesions, but can also develop into several other parts of the body, including the lungs, lymph nodes, and digestive system In the United States, the annual incidence of the disease is six parts per million and mainly affects people with low immune function Pomalyst is an oral drug that is the first new treatment approved for patients with Caposi sarcoma in more than 20 years "People with Carposhee sarcoma have had little control over the past 20 years," said Diane McDowell, vice president of global medical affairs at 's Perch Mespall Hematology We are pleased to have further research on Pomalyst in this rare area of disease, enabling us to provide patients with much-needed oral treatment options "Pomalyst showed positive results in patients with Caposi sarcoma, regardless of their HIV status," said Dr Robert Yarchan, Director of Oncology at the National Cancer Research Center (CCI) Cancer Research Center (CCI) HIV and
AIDS In addition, the drug provides an oral therapy with a different mechanism of action than the cytotoxic chemotherapy drugs commonly used to treat Caposi sarcoma "
, as stated in the black-box warning of the prescription information, Pomalyst may cause harm to the fetus and is prohibited in pregnant women Pomalyst is only available through the ® of the restricted distribution program PomalystREMS In patients treated with Pomalyst, deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke may occur, and thrombosis prevention should be given this approval, based on data from the Open Label, Single Arm I/II Phase 12-C-0047 study The study assessed the safety, pharmacokinetics and efficacy of Pomalyst in HIV-positive and HIV-negative patients with symptoms of Caposi sarcoma, most of whom had advanced disease the pilot was conducted by a team led by Robert Yarchoan under the Cooperative Research and Development Agreement (CRADA) A total of 28 cases (18 HIV-positive and 10 negative) received a 5 mg dose of Pomalyst, one daily oral, a total of 21 cycles (28 days for one cycle), until the disease progresses or is unacceptable toxicity The trial excluded patients with symptoms of pulmonary or visceral caposi sarcoma, a history of venous or arterial thrombosis, and coagulant disease Throughout the treatment, patients received an aspirin 81mg thrombosis treatment once a day The median time from initiation of treatment to the occurrence of first remission is 1.8 months (0.9-7.6) The primary endpoint of the study was the total remission rate (ORR, including complete remission of CR, clinical total remission of the CR, partial remission of the (PR), which was evaluated by the research investigators based on the response criteria of the Group of The of the AIDS Clinical Trials (ACTG ) and the Oncology Committee data show that among all patients, ORR was 71% (20/28; 95% CI: 51,87), of which 24% (4/28) reached CR and 57% (16/28) reached PR Median remission duration (DOR) was 12.1 months (95% CI: 7.6, 16.8) in all patients In addition, 50% of patients with remission maintained remission during 12 months of treatment with Pomalyst the most common adverse reactions, including laboratory abnormalities, are absolute count reduction of neutrophils or white blood cells, increased creatinine or glucose, rash, constipation, fatigue, hemoglobin, platelets, phosphate, albumin or calcium reduction, ALT elevation, nausea and diarrhea 11% (3/28) of patients were permanently discontinued due to adverse reactions No new safety signals were found In Caposi sarcoma, Pomalyst's safety is as the known safety of Pomalyst in approved indications Kaposisarcoma (KS) is a rare form of cancer that usually manifests itself as a skin lesions, but can also develop into several other parts of the body, including the lungs, lymph nodes, and digestive system Caposi sarcoma is caused by Caposi sarcoma-related herpes virus (KSHV, also known as human herpes virus type 8 (HHV-8) and is most common in people with HIV with impaired immune function Although the combination of antiretroviral therapy (cART or HAART) has reduced the incidence of Caposi sarcoma in the United States, the disease still occurs at a rate of about 6 cases per million people Caposi sarcoma is more common in areas with less AIDS treatment in the world, and in sub-Saharan Africa, where more people are infected with Caposi sarcoma-related herpes virus (KSHV), the most common tumor son sons in some of these countries Pomalyst is an immunomodulator with activity against tumors, a thalidomide analogue that has been approved for the treatment of adult patients: (1) combined with dexamethasone for the treatment of multiple myeloma (MM), specifically those previously received at least 2 treatments (specifically) These include patients who show progress oistomynization during the last treatment or within 60 days of treatment, and (2) patients with Kaposi sarcoma (KS), specifically those with HIV-negative KS who have failed TOS treatment for HAART treatment (biovalleybioon.com) original source: U.S Food and DrugAdministration
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roves Bristol Myers Squibb's Pomalyste (pomalidomide) for AIDS-Yn and HIV-KaposiKasiSara