Merck & Co.

Merck’s Keytruda wins FDA approval to treat head and neck cancer

Source: Reuters Date: June 11, 2019 Author: Reporting by Aakash Jagadeesh Babu; Editing by Shailesh Kuber (Reuters) - Merck & Co Inc said on Tuesday its blockbuster cancer drug Keytruda won approval from the U.S. Food and Drug Administration to treat a type of head and neck cancer. The drug was approved for use as a monotherapy, as well as in combination with a common chemotherapy regimen, to treat previously untreated patients with head and neck squamous cell carcinoma, Merck said. The approval is based on results from a late-stage trial, where Keytruda showed a significant improvement in overall survival in cancer patients, Merck said. Keytruda, a type of immunotherapy called a PD-1 inhibitor, is already an approved treatment for several forms of cancer, including lung and skin cancers. Head and neck cancer includes tumors in the mouth, tongue, nose, sinuses, throat and lymph nodes in the neck. Merck estimates that there will be more than 65,000 new cases of head and neck cancer diagnosed in 2019 in the United States. Keytruda works by increasing the ability of patients’ immune system to help detect and fight tumor cells. The drug has been amassing approvals as a standalone therapy and in combination with other drugs to treat several forms of cancer. It is the leading immunotherapy for treating lung cancer, ahead of rival drugs from Bristol-Myers Squibb, Roche and AstraZeneca. Keytruda, first approved for advanced melanoma in 2014, is Merck’s most important growth driver. It has overtaken Bristol’s Opdivo as the [...]

Brian Hill2019-06-12T09:48:16-07:00June, 2019|Oral Cancer News|

Merck’s Experimental HPV Vaccine Shows Promise in Late Stage Trial

Source: Nasdaq By: Peter Loftus Published: November 3, 2013 An experimental Merck & Co. vaccine appeared to provide broader protection against a cancer-causing virus than the company's Gardasil shot in clinical trials. Merck said the study results support its plan to submit the new vaccine, code-named V503, for U.S. regulatory approval by year's end, which could lead to market launch next year at the soonest. Merck expects health-care providers to eventually switch to V503 if the product receives marketing approval. Some analysts expect its annual sales could exceed $1 billion. "The case for using V503 is even stronger than the case for using Gardasil, which was already strong," said Roger Perlmutter, head of Merck's research and development unit. Dr. Perlmutter has singled out V503 as one of the programs Merck will focus on as it overhauls its R&D unit in a bid to recover from a series of setbacks. Gardasil, launched in 2006, was the first vaccine to protect against human papillomavirus, or HPV, a sexually transmitted virus that can cause cervical cancer in women and other less-common types of cancer in males and females. The U.S. Centers for Disease Control and Prevention recommends HPV vaccination of boys and girls ages 11 and 12, though it is approved to be given to people ages 9 to 26. GlaxoSmithKline also sells an HPV vaccine called Cervarix. Gardasil is designed to protect against four strains of HPV, two of which are believed to be responsible for about 70% of all cervical [...]

Charlotte Parker2013-11-05T11:13:34-07:00November, 2013|Oral Cancer News|

HPV Vaccine Not Linked To Autoimmune Disorders, Study

Source: MedicalNewsToday.com A two-year study of nearly 190,000 girls and women, finds that Gardasil, the human papillomavirus (HPV) vaccine made by Merck & Co, does not trigger autoimmune disorders such as lupus, rheumatoid arthritis, type 1 diabetes and multiple sclerosis. The results are published in the Journal of Internal Medicine. Study lead author Dr Chun Chao, a research scientist at the Kaiser Permanente Department of Research & Evaluation in Pasadena, California, said in a statement released on Friday, that: "This kind of safety information may help parents with vaccination decisions." ""These findings offer some assurance that among a large and generalizable female population, no safety signal for autoimmune conditions was found following HPV4 vaccination in routine clinical use," said Chao. Gardasil is a "quadrivalent" vaccine because it helps protect against 4 types of HPV. In girls and young women age 9 to 26, it targets 2 types that cause about 75% of cervical cancers, and 2 other types that cause 90% of cases of genital warts. The vaccine, which is given as three injections over six months, also helps protect boys and men age 9 to 26 against 90% of cases of genital warts. Genital warts is the most common sexually transmitted infection in the US, where it infects about 6.2 million people every year. It can also lead to cervical cancer in women. Gardasil received US Food and Drug Administration (FDA) approval in 2006. But a longstanding concern about links with autoimmune disorders has surrounded the vaccine, and many [...]

Charlotte Parker2012-02-03T10:40:12-07:00February, 2012|Oral Cancer News|

HPV related oral cancers continue to increase in the US

Source: International Medicine News CHICAGO – Human papillomavirus infection was firmly linked to the recent rise in oropharyngeal cancers in the United States, based on data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program. If current trends continue, the incidence of HPV-related oral cancers will soon surpass that of cervical cancers, senior author Dr. Maura Gillison reported at the annual meeting of the American Society of Clinical Oncology. The incidence of HPV-positive oropharyngeal cancers increased 225% – from 0.8 per 100,000 to 2.8 per 100,000 – between 1988 and 2004, the researchers found. At the same time, the incidence rate for HPV-negative oropharyngeal cancers, which are strongly related to tobacco and alcohol use, declined by 50% – from 2.0 per 100,000 to 1.0 per 100,000. Consequently, the overall incidence of oropharyngeal cancers increased 28%. Even by the conservative estimate that 70% of oropharyngeal cancers in 2020 will be HPV positive, the annual number of HPV-positive oral squamous cell carcinomas (8,653 cases) is expected to surpass cervical cancers (7,726 cases). Further, the majority will occur among men (7,426 cases), said Dr. Gillison, a medical oncologist and the Jeg Coughlin Chair in Cancer Research at Ohio State University Comprehensive Cancer Center in Columbus. Changes in sexual behavior among recent birth cohorts and increased oral HPV exposure probably influenced the increases in incidence and prevalence, Dr. Gillison speculated. Having a high lifetime number of sexual partners is a known risk factor for HPV infection. Although the rise in oral cancers [...]

Oral Cancer Foundation News Team - A2011-06-06T10:23:24-07:00June, 2011|Oral Cancer News|

FDA Advisory Committee recommends approval for use of GARDASIL® in boys and men

Source: www.merck.com Author: press release Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL¨ [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11. "Merck has been committed to pursuing the use of GARDASIL in both males and females since the vaccine was discovered over a decade ago," said Peter S. Kim, Ph.D., executive vice president, and president of Merck Research Laboratories. "We are pleased that the Advisory Committee agrees that the data support the use of GARDASIL in boys and men.” The committee’s recommendation will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) that Merck submitted for GARDASIL in December 2008. The FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing vaccines. Merck expects a decision from the FDA in the fourth quarter of 2009 after the agency has completed its review of Merck's application. “Today's discussion with the Advisory Committee brings the public health community closer to being able to provide GARDASIL to both men and women," said Anna R. Giuliano, Ph.D., Moffitt Cancer Center. GARDASIL has been approved for use in the U.S. since June 2006 and is [...]

Oral Cancer Foundation News Team - A2009-09-09T21:02:25-07:00September, 2009|Oral Cancer News|

Glaxo’s cervical cancer vaccine faces US battle

Source: Forbes.com Author: Linda A. Johnson New studies show GlaxoSmithKline PLC's vaccine Cervarix blocks the virus that causes cervical cancer, but if it wins approval for U.S. sales, it will face an uphill battle against Gardasil, which has owned the market here for three years. Cervarix, Glaxo's vaccine against human papilloma virus or HPV, already is approved in more than 90 other countries, but has been held up by delays in the United States. Several years ago, the British drugmaker was in a neck-and-neck race with rival Merck & Co., Gardasil's maker, to be first on the U.S. market, but it lost when Gardasil got approved in June 2006. Late in 2007, the Food and Drug Administration declined to approve approve Cervarix. GlaxoSmithKline submitted a new application on March 30 that included final data from an 18,000-woman study recently completed. Final results from that study and two others are being presented this weekend at a conference in Sweden on papillomavirus. FDA is expected to decide whether to approve Cervarix within several months. If it does, analyst Erik Gordon, a professor at the University of Michigan's Ross School of Business, said doctors who have prescribed Gardasil for a few years may see no reason to switch - unless GlaxoSmithKline convinces them its product is much more effective or has fewer side effects. Both vaccines target the two types of HPV that cause about 70 percent of cervical cancers, types 16 and 18, and data indicate both are about 98 percent effective. But Merck also [...]

Charlotte Parker2009-05-08T18:53:28-07:00May, 2009|Oral Cancer News|