#opdivo

[newstotalcomunicacao]

Anvisa manda apreender lotes falsos de Mounjaro e remédio para câncer

A  Agência Nacional de Vigilância Sanitária (Anvisa) determinou, nesta quinta-feira (4), a apreensão de um lote falsificado do medicamento Mounjaro e um outro lote de Opdivo, remédio usado no tratamento de câncer.  De acordo com a agência reguladora, está proibida a venda, distribuição e uso do lote 082024 do Mounjaro. Este lote foi produzido por uma empresa desconhecida após a Eli Lilly,…

Anvisa manda apreender lotes falsos de Mounjaro e remédio para câncer

[nuadox]

FDA approves first immunotherapy for initial treatment of gastric cancer

- By U.S. Food and Drug Administration (FDA) -

Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

“Today’s approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer.”

There are approximately 28,000 new diagnoses of gastric cancer each year in the U.S. With currently available therapy, overall survival is generally poor; the rate of cure with resection is very low and the survival rate for all stages is 32%. The 5-year survival rate for advanced or metastatic gastric cancer is 5%.

Opdivo is a monoclonal antibody that inhibits tumor growth by enhancing T-cell function. Its efficacy was evaluated in a randomized, multicenter, open-label trial of 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. The 789 patients who received Opdivo in combination with chemotherapy, on average, lived longer than the 792 patients who received chemotherapy alone. Median survival was 13.8 months for patients who received Opdivo plus chemotherapy compared to 11.6 months for patients who received chemotherapy alone.

The most common side effects of Opdivo in combination with chemotherapy include peripheral neuropathy (damage to the nerves outside of the brain and spinal cord), nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation and musculoskeletal pain. Opdivo can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis). Patients should tell their healthcare providers if they have immune system problems, lung or breathing problems, liver problems, have had an organ transplant, or are pregnant or plan to become pregnant before starting treatment.

Opdivo received Priority Review and Orphan Drug designations for this indication. Priority Review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

The FDA granted approval to Bristol-Myers Squibb Company.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, the FDA collaborated with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Source: U.S. Food and Drug Administration (FDA)

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[brooklynwildlife]

Yesterday was my last doctors appointment in reference to treatment /immunotherapy - all my bloodwork seems to have gone well. I took a cab because I'm still partially immunocompromised to be in the office for ten minutes 😿😹. Somebody needs to develop technology that allows people to draw blood at home or closer to where they live. Later had a telehealth discussion with my oncologist and he had some very kind words about my completing the regiment. The vitiligo is still spreading and he suggested that I'll have to start using sunscreen (welcome to white privilege). Ha... all in all it was a good day. If you have any questions about melanoma, pinky toe amputations, immunotherapy, addiction, and the mental health issues that correlate, hit me up and I can try to answer. . . . #melanoma #immunotherapy #opdivo #fcancer #survivor #newyork #memorialsloankettering #newyork #healthcare #obamacare #treatment #recovery https://www.instagram.com/p/CGYEouGFjrv/?igshid=9ei10z920ytu

[fromsciencetopharma]

FDA approves Opdivo, Yervoy combo for previously untreated unresectable MPM #FDA #Opdivo #Yervoy “Mesothelioma is a cancer caused by asbestos. It most commonly occurs in the linings of the lungs or the abdomen. The average life expectancy is 12 – 21 months after diagnosis, but prognosis may improve with treatment. Symptoms can include chest pain, shortness of breath and general fatigue. Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). “ #MSL #FSTP #MSLcert #medicalscienceliaison medical science liaison #Medicalaffairs medical affairs #Pharmacist #PHD #postdoclife https://www.instagram.com/p/CGBreI7Dmih/?igshid=rwry2r2q7pd

[fromsciencetopharma]

Merck's Keytruda sets up Opdivo showdown with esophageal cancer victory #opdivo #Keytruda #esophagealCancer “After archrival Opdivo from Bristol Myers Squibb posted a pair of esophageal cancer wins last week, Merck & Co.’s Keytruda is determined not to be left behind. The New Jersey drugmaker Wednesday said a combination of its PD-1 blockbuster plus chemo had topped chemo at keeping cancer at bay and extending patients’ lives in a trial of those with previously untreated advanced or metastatic disease. Full results are still under wraps, but the company is hoping to present them at next month’s European Society for Medical Oncology (ESMO) Virtual Congress.” https://www.instagram.com/p/CEF_WJkjZmz/?igshid=12w9gone63quq

[cancerabcs]

Positive Data from the ChecMate 650 Immunotherapy Study

Prostate cancer, unlike other cancers, has not been nearly as responsive to immunotherapies, especially in monotherapy approaches, then other cancers. 

A recent phase II clinical trial described at the 2019 ASCO GU meeting using a combination of two immunotherapy drugs in metastatic prostate cancer has shown some positive activity.

The trial, the CheckMate 650 Study, evaluated the combination of ipilimumab (Yervoy) and nivolumab (Opdivo) in 90 men with mCRPC who were divided into two cohorts based on their prior treatment. Cohort 1 was comprised of both symptomatic and minimally symptomatic men who progressed after treatment with second-generation hormone therapy (Zytiga or Xtandi) and had not received taxane based chemotherapy for mCRPC, and cohort 2 which included men who had also progressed after taxane-based chemotherapy.

The study data showed that "In a malignancy where immune checkpoint monotherapy has shown limited activity, nivolumab plus ipilimumab demonstrated antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC)," said study author Padmanee Sharma, MD, PhD, professor of Genitourinary Medical Oncology and Immunology at the University of Texas MD Anderson Cancer Center in Houston.

Subjects experienced, "Deep and durable object responses, as well as falls in prostate-specific antigen (PSA < 2 ng/mL) levels, were observed in a subgroup of patients," said Sharma, adding that the "preliminary data suggest that biomarkers have a role in identifying patients with mCRPC likely to respond to immunotherapy. "However, treatment tolerability was an issue.

Study subjects received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four doses, and then they received a maintenance therapy with nivolumab 480 mg every 4 weeks.

The combination showed an objective response rate of 25% in cohort 1 and 10% in cohort 2. There were two complete responses in each cohort, and partial responses were observed in six men in cohort 1 and one man in cohort 2. Additionally, 13 men achieved stable disease in cohort 1 and 11 men in cohort 2.

The authors concluded that there was a benefit regardless of prior exposure to chemotherapy, but the benefits appeared to be more pronounced in men who had not received prior chemotherapy.

Median time to response was 1.9 months in the first cohort and 2.1 months in the second cohort.

Prostate cancer needs more immunotherapy options.  Prior research shows us that the best approach to improve this option will be using combination therapy approaches.  This trial also reinforces the concept that we need better biomarker development so that we can know which men will be responsive before our spending money on treatments that will not have a positive result but will cause unnecessary side effects.

[blogglitterykingstudent-blog]

Trials Show Potential of Opdivo for Mesothelioma

Trials Show Potential of Opdivo for Mesothelioma

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One of the prominent areas of mesothelioma research today is around the development of an effective, tolerable, second-line treatment for recurrent cases. Studies have shown mesothelioma recurrence is highly prevalent, even among patients who are able to undergo aggressive primary therapy, like surgery. Some studies have noted recurrence rates ranging from 10 – 72% of patients.

Currentl…

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