Home » Blog » FDA Approves Gilead’s New Treatment for Large B-Cell Lymphoma, Astra and Merck Get Green Light for Fast Review of Lynparza, and More on This Week’s Innovation Partners BioBlog

FDA Approves Gilead’s New Treatment for Large B-Cell Lymphoma, Astra and Merck Get Green Light for Fast Review of Lynparza, and More on This Week’s Innovation Partners BioBlog

IP Blog | Innovation Partners | October 22, 2017

This week there’s breakthrough news emerging in the treatment of cancer. The FDA approved Gilead (Kite Pharma’s) gene-therapy treatment for large B-cell lymphoma, offering hope to many patients who didn’t respond well to other treatments. The “cascade of costs” associated with gene therapy, including treatment for side effects, is one factor pushing the price tag for such innovative treatments past the $1 million mark. The Trump Administration is making changes to the Affordable Care Act’s provisions, but will it have unintended consequences? These are the top stories in this week’s BioBlog. Read on for more breaking news from the world of healthcare.

FDA approves Gilead cancer gene therapy; price set at $373,000

The FDA approved Gilead (Kite Pharma)’s new gene-therapy treatment for large B-cell lymphoma, a type of non-Hodgkin lymphoma. The new treatment will be sold under the name Yescarta and will be used to treat patients who have not responded to other therapies. The list price for Yescarta, which is administered just once to a patient, is $373,000.

Trump promises action on drug prices

President Trump vowed to take action on the high cost of drugs, claiming “The world is taking advantage of us” because drugs are priced differently, often lower, in other nations compared to the United States. The administration has not released specific details on actions they might take to lower the cost of drugs, but drafts are circulating of an executive order that would lower barriers to entry so that increased competition lowers prices.

Executive Order on Access to Health Care In Fact Threatens Patient Access to High-Quality Cancer Care

ASCO’s president, Bruce E. Johnson M.D., penned a stern letter denouncing the Trump Administration’s executive order calling in part for federal rules to encourage association health plans. ASCO’s stance is that the new action may, in fact, reduce patient access to high-quality cancer care rather than broaden access.

Mayo Clinic Study Cites Race and Socioeconomic Factors as Influential in Non-Small Cell Lung Cancer (NSCLC) Patient Survival Rates

Race and socioeconomic factors may influence survival rates for patients diagnosed with non-small cell lung cancer. A Japanese study found that although overall, rates of survival for NSCLC patients have improved, the influence of race and socioeconomic factors has not been well studied.

Cascade of Costs Could Push New Gene Therapy Above $1 Million Per Patient

Gene therapy drugs aren’t cheap. The country’s first gene therapy treatment for leukemia, Novartis’ Kymriah, costs $475,000. However, the actual cost per patient for Kymriah and approximately 21 similar drugs in development may reach as high as $1 million per patient. A so-called “cascade of costs”, including treatment for serious side effects, pushes the price higher than the norm.

Health Care Back on Congress’s Front Burner

This week, the Senate continues to discuss President Donald Trump’s decision to stop subsidies to health insurers. Republicans are trying to keep the discussion going around conservative healthcare priorities, while doubt remains that there is a healthcare direction that will please both sides of the aisle.

Astra and Merck win speedy review for Lynparza in breast cancer

U.S. regulators have agreed to a priority review of AstraZeneca’s new ovarian cancer treatment drug, Lynparza, as a potential treatment for breast cancer. If the review proves positive, the drug could be available as early as 2018 as a potential breast cancer treatment option. Lynparza is being jointly developed and marketed with Merck. It is the first poly ADP-ribose polymerase treatment drug considered for us outside of the treatment of ovarian cancer.

Men Found Six Times More Likely Than Women To Have Highest Risk HPV Infection

Men are three times more likely than woman to carry the oral infection of human papillomavirus (HPV). This virus causes 31,500 cases of new cancer each year in the United States. The HPV strain responsible for cervical cancer in women is also six times more prevalent in men. The National Cancer Institute found that 11.5 million men and 3.2 million women have oral HPV infections at any given time.

Insurance Plays Significant Role in Breast Cancer Disparities

Black women face a greater risk of death from breast cancer. According to new research, this may be in part to a disparity in insurance coverage. The Journal of Clinical Oncology concluded in a recent article that equal access to care may address the disparity between outcomes for black and white women.

Medicaid is the biggest winner in Trump’s Obamacare subsidy cuts

A key component of the Affordable Care Act (Obamacare) was the Federal insurance subsidy payments for low-income people. Now, with the Trump Administration canceling these payments, the net effect over time is expected to be an increase in insurance premiums. It is also thought that it will force people to remain on Medicaid longer. A look at the unintended consequences of changes to Obamacare and how it may impact various groups.

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