Real-Time Oncology Review

Earlier this week, FDA granted its first approval as a part of two new pilot programs that aim to make the development and review of cancer drugs more efficient. The drug is Novartis’ Kisqali and the two programs are the Real-Time Oncology Review (allows for the FDA to review much of the data earlier, after the clinical trial results become available and the database is locked) and the Assessment Aid Pilot Project (used by sponsors to organize their submission into a structured format to facilitate FDA’s review of the application). FDA Commissioner Gottlieb says, “With today’s approval, FDA used these approaches to allow the review team to start analyzing data before the submission of the application and help guide sponsor’s analysis of the top-line data.” Looking for a heavyweight fight? Watch sales of Pfizer Ibrance vs. Novartis Kisqali.

We want you

DYK that ~86% of clinical trials don’t reach recruitment targets within their specified time periods? Did ya? And, DYK that fewer than 5% of adult cancer patients enroll in cancer clinical trials? If you’re in the clinical development space, this is not news to you and we’re here to tell you that CISCRP is trying to do something about it. Not to be confused with Cocoa Krispies, CISCRP is a non-profit organization founded in 2003 and dedicated to educating the public and patients and to engaging these critical stakeholders as partners in the clinical research process. As part of their marching orders, they have developed a “Medical Heroes Campaign” to re-brand how the public thinks about clinical research and those who volunteer for clinical trials. To see the June supplement in USA Today go here. Remember, no clinical trial volunteers, no new medicines. Mic drop.

Cancer caused by CRISPR?

Two studies released this week looked at the tumor-suppressing gene p53 and found that it doesn’t play nicely with CRISPR-Cas9. P53 is responsible for scrambling emergency services when DNA is damaged, which CRISPR-Cas9 does when cutting into DNA strands and adding some new DNA. The emergency response is a take-no-prisoners approach which either ‘fixes’ the DNA, rendering the gene therapy useless, or kills the cell. Astute readers may notice this also makes the therapy useless. That could answer why gene editing can be inefficient, and that’s also where the cancer risk comes in. The only cells that survive this process have faulty p53 genes, thus compromising the cells’ ability to fight future tumors. This was only observed with the DNA insertion process, so don’t sound the death knell for CRISPR just yet.

Cancer spending up. Duh.

According to a new report by the IQVIA Institute for Human Data Science, spending on cancer therapies has doubled over the past 5 years. And the retail price tag on these drugs is up, too. The average retail price of the 2017 launches was over $150,000, compared to $79,000 for those launched in 2013. You know, when they were practically garage sale prices. But before we get our knickers in a twist, IQVIA reports the average annual out-of-pocket spend for someone with commercial health insurance was just $500. With 1.7 million cancer diagnoses and over 600,000 deaths in the US alone forecast for 2018, that doesn’t seem like such a bad deal.

You’re my boy blue

This week, researchers from MD Anderson reported “significant durable disease control seen in patients with lung and thyroid cancers harboring the RET oncogene.” This is great news for people with the RET alteration. RET is linked to half of all medullary thyroid cancers, 20% of papillary thyroid cancers and 1-2% of non-small cell lung cancers. The phase I study of the compound BLU-667 from Blueprint Medicines is being conducted with 84 patients. According to lead investigator Vivek Subbiah “the data show the precision targeted therapy with next-generation kinase inhibitors can have a powerful impact for patients with RET-driven cancers.” All this seems great, unless you own Blueprint stock, which dropped 9% on the news. Wall Street. Anyway, here’s hoping the drug will show continued durability and effectiveness. You’re my boy blue!

This week, coffee bad

Every week it seems science determines coffee is alternately a health benefit and a health detriment. Well, a California judge has declared it settled. If the ruling stands, all California coffee sellers will be forced to place a cancer warning at the point of purchase. Plaintiffs in the case claimed—and apparently demonstrated—that the chemical acrylamide, produced as beans are roasted, increases the risk of cancer. Defendants lead by the likes of Starbucks claimed—and apparently failed to demonstrate—that the levels of acrylamide are not harmful, that coffee has health benefits that outweigh any potential harm, and that they can’t remove the chemical without altering the flavor. Like Shania Twain, the judge said, that don’t impress me much. The good news? If the ruling is upheld, coffee will still only cause cancer in California. Coffee-Cat meme.

Trade wars don’t include cancer drugs

US stock markets have been roiling over a possible trade war between the world’s largest economies, the US and China. American President Donald Trump proposed nearly $50B in tariffs on Chinese goods, leading Chinese leaders to propose some of their own, but one product they’re not interested in taxing is foreign cancer drugs. China does have the world’s largest population of cancer patients after all. Drugmakers like Roche, Novartis and AZ should be pretty happy with the zero-tariff arrangement, while Chinese leadership hopes the move will push local pharma to improve their technological capabilities. Why can’t we go back to the good ol’ days when both the Chinese and Americans could ask “War, HUH, yeah, what is it good for?”

Take this cancer test with a shaker full of salt

Genetics company 23andMe—popular for their DTC ancestry tests—has been FDA approved for their mail-order breast cancer tests. Consumers can check whether they possess one of three mutations to their aptly-named BRCA1 and BRCA2 genes, which increase breast cancer risk by 45%-85%. Thing is, there are 1,000 known variations of those genes, and it doesn’t even test the most common. Also, the genes tested mainly affect women of Ashkenazi Jewish descent. Also, if a patient doesn’t test positive for these mutations they may think they’re in the clear breast cancer-wise. Also, some physicians are worried about the mental health effects of learning you may be at risk for cancer without being counseled through it by a professional. But hey, they send the tests to your home so that’s convenient!