Merck

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 Keytruda looks to zoom past Opdivo with fast head and neck cancer review

Source: Fierce Pharma Date: February 11, 2019 Author: Carly Helfand Merck & Co.’s Keytruda is duking it out with Bristol-Myers Squibb’s Opdivo in the head and neck cancer marketplace, but Keytruda just took one step toward a green light that would give it a big edge. The FDA has tagged Merck’s approval application for the immuno-oncology superstar—alone or in tandem with chemo—with its priority review designation in previously untreated patients with head and neck cancer. The move, which Merck announced Monday, sets Keytruda up for a quick trip down the regulatory pathway; the agency expects to have a decision by June 10, Merck said. FDA staffers based their decision on data Merck trotted out at last year’s European Society for Medical Oncology (ESMO) meeting in October. Results showed that solo Keytruda, when pitted against a standard-of-care regimen dubbed by doctors as “Extreme,” could cut the risk of death by 22% in patients testing positive for the biomarker PD-L1. In patients with high levels of PD-L1 in their tumors, that figure shot up to 39%. And when paired with chemo, Keytruda pared down the risk of death by 23% regardless of patients’ PD-L1 status. Based on “the limited interaction we’ve had with key opinion leaders, I think this is seen as practice-changing,” Roy Baynes, Merck SVP and head of global clinical development, said when the data were released. And in addition to shaping opinions on clinical practice, the results also confirmed Keytruda’s place in the second-line setting, where it had previously suffered a narrow trial miss. [...]

Charlotte Parker2019-02-11T11:48:00-07:00February, 2019|Oral Cancer News|

ASCO Urges Aggressive Efforts to Increase HPV Vaccination

Source: www.medscape.comAuthor: Zosia Chustecka Human papillomavirus (HPV) vaccines have now been available for 10 years, but despite many medical professional bodies strongly recommending the vaccine, uptake in the United States remains low. Data from a national survey show that about 36% of girls and 14% of boys have received the full schedule of HPV vaccines needed to provide protection (Vaccine. 2013;31:1673-1679). Now the American Society of Clinical Oncology (ASCO) has become involved, and in a position statement issued today the organization calls for aggressive efforts to increase uptake of the HPV vaccines to "protect young people from life-threatening cancers." "With safe and effective vaccines readily available, no young person today should have to face the devastating diagnosis of a preventable cancer like cervical cancer. But unless we rapidly increase vaccination rates for boys and girls, many of them will," ASCO President Julie M. Vose, MD, said in a statement. "As oncologists, we see the terrible effects of these cancers first hand, and we have to contribute to improving today's alarmingly low vaccination rates," she added. The new policy statement is published online April 11 in the Journal of Clinical Oncology. The statement notes that HPV vaccination has been previously recommended by many US medical societies, including the American Cancer Society, the American College of Obstetrics and Gynecology Committee, the American Dental Association, the American Head and Neck Society, the American Nurses Association, the American Pharmacists Association, the Association of Immunization Managers, the Society for Adolescent Medicine, and the Society of Gynecologic Oncology. [...]

Charlotte Parker2016-04-18T13:12:04-07:00April, 2016|Oral Cancer News|

Merck Says FDA Accepts Its SBLA For Keytruda For Treatment Of Head & Neck Cancer

Source: www.finchannel.comAuthor: Fin Channel News Editorial Staff The FINANCIAL -- Merck, known as MSD outside the United States and Canada, on April 13 announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The application is seeking approval for KEYTRUDA as a single agent at a dose of 200 mg administered intravenously every three weeks. The FDA granted Priority Review with a PDUFA, or target action, date of Aug. 9; the sBLA will be reviewed under the FDA’s Accelerated Approval program, according to Merck. “Starting in the early days of our development program, we have explored the role of KEYTRUDA for patients with head and neck cancer, a difficult-to-treat and debilitating disease with very few treatment options,” said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We are encouraged by the data emerging from our program in this type of cancer, and welcome today’s news as this is an important step toward making KEYTRUDA available to these patients.” Merck currently has the largest immuno-oncology clinical development program in head and neck cancer and is advancing multiple registration-enabling studies with KEYTRUDA as a single agent and in combination with chemotherapy. *This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness [...]

Charlotte Parker2016-04-13T11:58:01-07:00April, 2016|Oral Cancer News|

Expanded age indication cleared for Gardasil 9 in males

Source: www.FormularyJournal.ModernMedicine.comAuthor: Erin Bastick FDA approved an expanded age indication for Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9, Merck) in males. Seven HPV types in Gardasil 9 (HPV 16, 18, 31, 33, 45, 52, and 58) cause approximately 90% to 95% of HPV-related anal cancers, 90% of cervical cancers, and 80% of high-grade cervical lesions worldwide.These 7 types also cause the majority of HPV-related vulvar and vaginal cancers. Gardasil 9 includes the greatest number of HPV (Human Papillomavirus) types of any available HPV vaccine. Gardasil 9 was previously approved for use in girls and young women aged 9 to 26 years for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 22, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. As for use in male patients, the vaccine was previously approved for use in boys aged 9 to 15 years for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. With the newest approval, Gardasil 9 is now also indicated for use in males aged 16 to 26 years for the prevention of these diseases. According to the CDC, HPV vaccination rates are unacceptably low compared to rates for other adolescent vaccines, and vaccination coverage in [...]

Charlotte Parker2015-12-30T18:31:17-07:00December, 2015|Oral Cancer News|

Here’s why the drug that helped Jimmy Carter get ‘cancer-free’ is such a big deal

Source: www.businessinsider.comAuthor: Lydia Ramsey Former US President Jimmy Carter announced on Sunday that his latest brain scan showed no sign of cancer, a few months after revealing that he had been diagnosed with melanoma that had spread from his liver to his brain. Carter was being treated with a cancer drug called Keytruda that uses the immune system to fight off cancerous cells. Keytruda, made by pharmaceutical company Merck, was originally approved by the FDA in September 2014 to treat melanoma, a deadly form of skin cancer that can also show up in other organs of the body, as it did in Carter's case. In someone with melanoma, certain proteins called PD-1 stop the immune system from doing its job and fighting the cancerous cells. Keytruda works by getting in the way of those proteins, allowing the immune system to access the cancer cells. Then, with the help of radiation therapy, which works to shrink tumors by killing cancer cells, it can knock the cancer out. The drug is delivered intravenously every three weeks, costing about $12,500 a month. And the drug isn't just being used in cases like Carter's. Keytruda, which got approved to treat a form of lung cancer in October, is also being explored to treat a number of other cancers, including head and neck, breast, and bladder cancers and Hodgkin lymphoma. It's also not the first cancer immunotherapy drug. Scientists have been seriously exploring using the immune system to battle cancerous cells for decades as an alternative to chemotherapy, radiation therapy, and surgery. But it's taken a long time for [...]

Oral Cancer Foundation News Team - A2015-12-09T10:45:24-07:00December, 2015|Oral Cancer News|

Merck immunotherapy appears effective in head and neck cancer – study | Reuters

Source: www.firstpress.comAuthor: Bill Berkrot A Merck & Co drug that helps the immune system fight cancer was about twice as effective as the current standard therapy for patients with recurrent or advanced head and neck cancers, according to study data released on Friday. A quarter of the 132 patients who received the drug, Keytruda (pembrolizumab), saw their tumors shrink by at least 30 percent. Fifty-six percent of patients experienced at least some tumor shrinkage in the ongoing single drug Phase I study dubbed Keynote-012, researchers reported. "This is remarkable because we don't usually see this level of activity with new agents. We have a track record of failure," said Dr. Tanguy Seiwert, lead investigator of the study from the University of Chicago. Advanced head and neck cancer is currently treated with Eli Lilly's Erbitux, known chemically as cetuximab, which typically has a response rate of 10 percent to 13 percent. "The only thing that works is cetuximab and this looks at least twice as good," said Seiwert, who was presenting the Keytruda data at the American Society of Clinical Oncology meeting in Chicago. ADVERTISING Merck shares rose more than 1 percent to $60.43 on the New York Stock Exchange. Keytruda and Opdivo from Bristol-Myers Squibb Co are at the forefront of a promising new class of drugs called PD-1 inhibitors that block a mechanism tumors use to evade the immune system. Keytruda is approved to treat advanced melanoma and awaits a decision for use in lung cancer. It is being [...]

Oral Cancer Foundation News Team - A2015-06-02T11:56:50-07:00June, 2015|Oral Cancer News|

Germany’s Merck halts supply of cancer drug to Greek hospitals

Source: Reuters.com Date: November 3, 2012 German pharmaceuticals firm Merck KGaA is no longer delivering cancer drug Erbitux to Greek hospitals, a spokesman said on Saturday, the latest sign of how an economic and budget crisis is hurting frontline public services. Drugmakers raised concerns with EU leaders earlier this year over supplies to the euro zone's crisis-hit southern half and Germany's Biotest in June was the first to stop shipments to Greece because of unpaid bills. Publicly-owned hospitals in some countries worst hit by the euro zone debt crisis had been struggling to pay their bills, Merck's chief financial officer, Matthias Zachert, was quoted as saying by German paper Boersen-Zeitung in an interview on Saturday. He said however that the only country where Merck had stopped deliveries was Greece. "It only affects Greece, where we have been faced with many problems. It's just the one product," he told the paper. A spokesman for the company told Reuters that the drug concerned was Erbitux and that ordinary Greeks can still purchase it from pharmacies. Some countries have taken action to pay bills, such as in Spain, where the government has said it will help hospitals to pay off debts. "That has improved things, even though the situation should still be regarded as critical for the coming years," Zachert said. Erbitux is Merck's second best-selling prescription drug, bringing in sales of 855 million euros ($1.1 billion) in 2011 from treating bowel cancer and head and neck cancer. ($1 = 0.7785 euros) This news story was resourced by the Oral Cancer [...]

Charlotte Parker2012-11-05T11:16:35-07:00November, 2012|Oral Cancer News|

Viral Marketing: What’s Stopping Men From Getting the HPV Vaccine

Source: GOOD Mobile By: Jake Blumgart on July 6, 2012 at 3:00AM PDT In early 2011, my doctor informed me that a vaccine to protect against the human papillomavirus—HPV—was now available for men. I was relieved, then frustrated—my doctor didn’t actually offer the principal vaccine, Gardasil, to her male patients. After a couple days of hunting around town, I finally found the vaccine at the Mazzoni Center, a LGBT health clinic in downtown Philly. I received all three shots, and joined the less than 1 percent of American men who are vaccinated against the most dangerous strains of the virus. While I was exceedingly grateful to the Mazzoni Center inoculating me, I knew of only one other male friend who’d received his shots. So since I got my shots, I’ve made a point of discussing my experience with any friend, acquaintance, or bemused bystander who will listen. And I’ve learned two things about young, straight men and HPV: We all know it exists, and not much else. When I posted about my vaccinations on Facebook and Twitter, the response was largely positive—but the dozen or so likes and comments mainly came from my female friends. When I brought up the issue with a few straight guys, they seemed confused about my decision to air the information in public. Embarrassed, I let the conversation drop. But a couple weeks later, I received a Facebook message from an acquaintance in another city, freaking out about his own HPV scare, and asking me whether [...]

Charlotte Parker2012-07-09T09:04:05-07:00July, 2012|OCF In The News, Oral Cancer News|

The Gardasil Problem: How The U.S. Lost Faith In A Promising Vaccine

Source: Forbes Magazine, written by Matthew Herper Neal Fowler, 50, the chief executive officer of a tiny biotech called Liquidia, was assuming a position common to road-warrior entrepreneurs: leaning his elbows on the seat-back tray in an airplane so he could gaze at the screen of his laptop. That’s when he felt the lump in his neck. Fowler, a pharmacist, figured his lymph node was swollen by a recent cold, but the oncologist seated next to him—his chairman of the board—thought they’d better keep an eye on it. The chairman was right. Over the next week the lymph node got bigger and harder. It was not sore to the touch, as happens during a cold. Fowler went to the doctor, then a specialist who knew exactly what he was seeing: a new form of throat cancer that ear, nose and throat specialists across the U.S. now say dominates their practices. Some 8,000 of these tonsil tumors turn up each year nationwide, courtesy of strain 16 of the human papilloma virus—the same sexually transmitted virus that causes cervical cancer. Usually transmitted when men perform oral sex on women, it can also spread through other forms of contact, perhaps even just kissing. His prognosis was good—80% of those with this new tumor survive. His status as a drug industry veteran and chief executive of a biotechnology company didn’t hurt, either. He went from diagnosis to having the primary tumor removed from his tonsil in just a day. His first team of doctors [...]

Charlotte Parker2012-04-05T21:25:34-07:00April, 2012|Oral Cancer News|