|
List Of Drugs Granted Breakthrough Therapy Designation
Below is a list of drugs granted breakthrough therapy designation (BTD) by the Food and Drug Administration (FDA). Drugs may be listed more than once as BTD can be awarded for multiple indications. 2020 D-PLEX 100 , , PolyPid Ltd, , Prevention of Surgical Site Infections (SSI) Prevention may refer to: Health and medicine * Preventive healthcare, measures to prevent diseases or injuries rather than curing them or treating their symptoms General safety * Crime prevention, the attempt to reduce deter crime and crimin ... 2019 2018 2017 2016 2015 2014 2013 References {{reflist Breakthrough therapy ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Breakthrough Therapy
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition; rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review. Requirements A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Urothelial Cancer
Transitional cell carcinoma, also called urothelial carcinoma, is a type of cancer that typically occurs in the urinary system. It is the most common type of bladder cancer and cancer of the ureter, urethra, and urachus. It accounts for 95% of bladder cancer cases. It is the second most common type of kidney cancer, but accounts for only five to 10 percent of all primary renal malignant tumors. Transitional cell carcinomas arise from the transitional epithelium, a tissue lining the inner surface of these hollow organs. When the term "urothelial" is used, it specifically refers to a carcinoma of the urothelium, meaning a transitional cell carcinomas of the urinary system. Signs and symptoms Signs and symptoms of transitional cell carcinomas depend on the location and extent of the cancer. Causes Urothelial carcinoma is a prototypical example of a Malignancies, malignancy arising from environmental carcinogenic influences. By far the most important cause is Smoking, cigarette ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Selpercatinib
Selpercatinib, sold under the brand name Retevmo among others, is a medication for the treatment of cancers in people whose tumors have an alteration (mutation or fusion) in a specific gene (RET (gene), RET which is short for "rearranged during transfection"). It is taken by mouth. The most common side effects include changes in laboratory tests (including increased liver enzymes, increased blood sugar, decreased white cell and platelet counts, decreased protein level, decreased calcium, increased total cholesterol, increased creatinine, and decreased sodium) dry mouth, diarrhea, high blood pressure, fatigue, edema, rash, and constipation. Selpercatinib is a kinase inhibitor, meaning it blocks a type of enzyme (kinase) and helps prevent the cancer cells from growing. Before beginning treatment, the identification of a RET gene alteration must be determined using laboratory testing. Selpercatinib is the first therapy approved specifically for people with cancer and the RET gen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Non-small-cell Lung Carcinoma
Non-small-cell lung cancer (NSCLC) is any type of epithelial lung cancer other than small-cell lung carcinoma (SCLC). NSCLC accounts for about 85% of all lung cancers. As a class, NSCLCs are relatively insensitive to chemotherapy, compared to small-cell carcinoma. When possible, they are primarily treated by surgical resection with curative intent, although chemotherapy has been used increasingly both preoperatively (Neoadjuvant therapy, neoadjuvant chemotherapy) and postoperatively (Adjuvant therapy, adjuvant chemotherapy). Types The most common types of NSCLC are squamous-cell carcinoma, large-cell carcinoma, and adenocarcinoma, but several other types occur less frequently. A few of the less common types are pleomorphic, carcinoid tumor, salivary gland carcinoma, and unclassified carcinoma. All types can occur in unusual histologic variants and as mixed cell-type combinations. Nonsquamous-cell carcinoma almost occupies the half of NSCLC. In the tissue classification, the cent ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Novartis
Novartis AG is a Swiss-American multinational pharmaceutical corporation based in Basel, Switzerland and Cambridge, Massachusetts, United States (global research).name="novartis.com">https://www.novartis.com/research-development/research-locations It is one of the largest pharmaceutical companies in the world. Novartis manufactures the drugs clozapine (Clozaril), diclofenac (Voltaren; sold to GlaxoSmithKline in 2015 deal), carbamazepine (Tegretol), valsartan (Diovan), imatinib mesylate (Gleevec/Glivec), cyclosporine (Neoral/Sandimmune), letrozole (Femara), methylphenidate (Ritalin; production ceased 2020), terbinafine (Lamisil), deferasirox (Exjade), and others. In March 1996, the companies Ciba-Geigy and Sandoz merged to form Novartis; the pharmaceutical and agrochemical divisions of both companies formed Novartis as an independent entity. Other Ciba-Geigy and Sandoz businesses were sold, or, like Ciba Specialty Chemicals, spun off as independent companies. The Sandoz brand ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Capmatinib
Capmatinib, sold under the brand name Tabrecta, is a medication for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to the exon 14 skipping of the ''MET'' gene, which codes for the membrane receptor HGFR, as detected by an FDA-approved test. The most common adverse reactions are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. Non-small cell lung cancer (NSCLC) is a disease in which malignant cancer cells form in the tissues of the lung. It is the most common type of lung cancer with up to 90% of all lung carcinomas falling into the non-small cell category. NSCLC occurs when healthy cells become abnormal and grow rapidly. One danger of this form of cancer is that there's a high likelihood that the cancer cells will spread from the lungs to other organs and body parts. Cancer metastasis consists of a sequential series of events, and MET exon 14 skipping is recognized as a critical even ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Triple-negative Breast Cancer
Triple-negative breast cancer (TNBC) is any breast cancer that lacks or show low levels of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) overexpression and/or gene amplification (i.e. the tumor is negative on all three tests giving the name ''triple-negative''). Triple-negative is sometimes used as a surrogate term for basal-like. Triple-negative breast cancer comprises 15–20% of all breast cancer cases and affects more young women or women with a mutation in the BRCA1 gene than other breast cancers. Triple-negative breast cancers comprise a very heterogeneous group of cancers. TNBC is the most challenging breast cancer type to treat. Hormone therapy that is used for other breast cancers does not work for TNBC. In its early stages, the cancer is typically treated through surgery, radiation and chemotherapy. In later stages where surgery is not possible or the cancer has spread from the initial localised area, treatment i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Immunomedics
Immunomedics was a biotechnology company focused on the development of antibody-drug conjugates for the treatment of cancer. In 2020, the company was acquired by Gilead Sciences. History Immunomedics was founded in July 1982 by David M. Goldenberg. Michael Pehl was named CEO in December 2017 but left due to personal reasons in February 2019. At that time, Dr. Behzad Aghazadeh was named Executive Chairman. In October 2020, Gilead Sciences acquired the company. In March 2022, Gilead announced the closing of the former Immunomedics facility in Morris Plains. Products * Epratuzumab is a humanized anti-CD22 monoclonal antibody in phase III trials for pediatric leukemia. * Sacituzumab govitecan (IMMU-132 / Trodelvy) is an anti-Trop-2-SN-38 antibody-drug conjugate for breast cancer and solid tumors. It was approved in April 2020 by the FDA for the treatment of adult patients with metastatic triple-negative breast cancer Breast cancer is cancer that develops from breast tiss ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Trodelvy
Sacituzumab govitecan, sold under the brand name Trodelvy, is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate used for the treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer. The most common side effects include nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia (hair loss), constipation, decreased appetite, rash and abdominal pain. Sacituzumab govitecan has a boxed warning about the risk of severe neutropenia (abnormally low levels of white blood cells) and severe diarrhea. Sacituzumab govitecan may cause harm to a developing fetus or newborn baby. Women are advised not to breastfeed while on sacituzumab govitecan and one month after the last dose is administered. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) consider it to be a first-in-class medication. Sacituzumab govitecan was approved for medical use in the European Union in November 2021. Medical uses Sacit ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cholangiocarcinoma
Cholangiocarcinoma, also known as bile duct cancer, is a type of cancer that forms in the bile ducts. Symptoms of cholangiocarcinoma may include abdominal pain, yellowish skin, weight loss, generalized itching, and fever. Light colored stool or dark urine may also occur. Other biliary tract cancers include gallbladder cancer and cancer of the ampulla of Vater. Risk factors for cholangiocarcinoma include primary sclerosing cholangitis (an inflammatory disease of the bile ducts), ulcerative colitis, cirrhosis, hepatitis C, hepatitis B, infection with certain liver flukes, and some congenital liver malformations. However, most people have no identifiable risk factors. The diagnosis is suspected based on a combination of blood tests, medical imaging, endoscopy, and sometimes surgical exploration. The disease is confirmed by examination of cells from the tumor under a microscope. It is typically an adenocarcinoma (a cancer that forms glands or secretes mucin). Cholangioca ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Incyte Corp
Incyte is an American multinational pharmaceutical company with headquarters in Wilmington, Delaware, and Morges, Switzerland. The company was created in 2002 through the merger of Incyte Pharmaceuticals, founded in Palo Alto, California in 1991 and Incyte Genomics, Inc. of Delaware. The company currently operates manufacturing and R&D locations in North America, Europe, and Asia. Incyte Corporation currently develops and manufacturers prescription biopharmaceutical medications in multiple therapeutic areas including oncology, inflammation, and autoimmunity. History In 2014, Incyte named Hervé Hoppenot president and CEO, and in 2015 he was appointed chairman of the Board of Directors. Hoppenot had previously served as the president of Novartis Oncology; he had been with Novartis since 2003. In September 2015, the company announced it had gained exclusive development and commercial right pertaining to Jiangsu Hengrui Medicine Co., Ltd's anti-PD-1 monoclonal antibody, SHR-121 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pemigatinib
Pemigatinib, sold under the brand name Pemazyre, is an anti-cancer medication used for the treatment of bile duct cancer (cholangiocarcinoma). Pemigatinib works by blocking FGFR2 in tumor cells to prevent them from growing and spreading. Pemigatinib belongs to a group of medicines called protein kinase inhibitors. It works by blocking enzymes known as protein kinases, particularly those that are part of receptors (targets) called fibroblast growth factor receptors (FGFRs). FGFRs are found on the surface of cancer cells and are involved in the growth and spread of the cancer cells. By blocking the tyrosine kinases in FGFRs, pemigatinib is expected to reduce the growth and spread of the cancer. The most common adverse reactions are hyperphosphatemia and hypophosphatemia (electrolyte disorders), alopecia (spot baldness), diarrhea, nail toxicity, fatigue, dysgeusia (taste distortion), nausea, constipation, stomatitis (sore or inflammation inside the mouth), dry eye, dry mouth, de ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
