I know that title is a little click-baity, but I couldn't come up with something short that really captured the complexity of this issue. The Journal of the American Medical Association published a study last week that looked at treatments that were given Accelerated Approval in the last 10 years. It's called "Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval." The question they sought to answer (and this is quoted from the article) was "What is the clinical benefit of cancer drugs granted accelerated approval, and on what basis are they converted to ..read more

There's a really interesting speaker series that happens every year in New York City called "Great Debates and Updates in Hematological Malignancies." Basically, a bunch of famous oncologists get together, two of them pick sides of a debate about blood cancer, each one speaks for a while, some others comment on what they said, and they move on to the next debate. It's probably a little bit misleading to call them "debates." I'm not sure they really expect there to be winners and losers. It's more like they are exploring together, looking at issues that don't have definite answers, and offering ..read more

I saw an article a few days ago that caught my attention. It's from The Guardian, written by an oncologist from Australia, and it's called "Patients keep asking if they should take cannabis for their cancer. The answer is still no." That title -- with it's "No" at the end -- reminded me of a sign that I saw once in a doctor's office. The doctor was a pain specialist, and I was there with a loved one. The sign said, in big letters, "If you are using marijuana for any reason, WE WILL NOT TREAT YOU!" Those are both very strong statements from doctors, and they show clearly how against cannabis us ..read more

A small pharma company announced today that it was submitting an Investigational New Drug (IND) application to the FDA for what they are calling "CAR-T 2.0," a newer, better version of CAR-T (or so they hope). The treatment is called SynKIR-310, and the phase 1 trial will be patients with relapsed/refractory B-cell Lymphomas, including Diffuse Large B Cell lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, and Marginal Zone Lymphoma. Their treatment includes a couple of differences when compared to current CAR-T treatments. They call theirs KIR-CAR, the "KIR" being "Killer-Cell Immunoglobin ..read more

I've been thinking about cancer a lot lately. That's no surprise. There hasn't been a day in 16+ years that I haven't thought about cancer. It's a side effect of being a cancer patient, as well as a blogger who needs content. But I'm also keeping an eye on a couple of other folks who both have cancer. They are people that I work with. I've known them for years, though I wouldn't say I'm personally close with them. Their diagnoses have an effect on my job, so they told me about it before they told most people. They also know about my own diagnosis from years back, so I think they trust me to be ..read more

Here's a kind of fun item for you Cancer Nerds: the website Fierce Pharma is holding a "drug name tournament" for the next few weeks. Some background for you first. In the U.S., we are just beginning the period known as "March Madness." College basketball is a big deal to many people in this country, and this week, the NCAA tournament begins. This involves 64 basketball teams that will play each other to determine who the national champion is. (I know it's actually 68 teams, but we're not going to complicate this any more than necessary.) And there are actually two tournaments, one for men's t ..read more

 A follow-up to the news from a few months ago that the FDA was issuing a warning about CAR-T causing secondary cancers. After reports of patients who had received CAR-T developing T cell cancers, the warning was issued in January.  The concern was that the patients were developing T cell cancers specifically. CAR-T, of course, currently made for each individual patient who receives the treatment. T cells are removed from the patient, manipulated to recognize cancer cells, and put back into the patient. Because the T cells are manipulated, the concern is that the process might go wro ..read more

Yesterday, the FDA granted accelerated approval for the combination of Zanubrutinib and Obinutuzumab for Relaped/Refractory Follicular Lymphoma patients who have had at least two previous treatments. this is good news -- we have another option. Zanubrutinib is an inhibitor. It's different from the PI3K inhibitors that have been approved (and then pulled) in the last few years. But it works on the same very general principle of inhibiting (or stopping) a process from happening that cancer cells need to grow and live.  Zanubrutinib is a Bruton tyrosine kinase (BTK) inhibitor. BTK is an enzy ..read more

The website BioSpace posted a really interesting article a coupe of weeks ago called "How Will FDA’s Pivot to Overall Survival Affect Cancer Drug Development?"  In my last post, I mentioned that I was a little surprised that the FDA was considering accelerated approval for the bispecific Epcoritamab, and that I had been doing some reading lately about the FDA potentialy changing the way they approve cancer treatments. The BioSpace article is a nice summary of the kind of things I have been reading. As the article points out, over the summer, there was a workshop at the American Associatio ..read more

A quick bit of news: The FDA granted Priority Review status to Epcoritamab for Relapsed/Refractory Follicular Lymphoma. Epcoritamab is a bispecific antibody. As a bispecific, Epcoritamab acts like a monoclonal antibody like Rituxan, by seeking out and attaching to a protein on the cancer cell (in this case, it attaches to the CD20 protein, just as Rituxan does). But then it dos something else -- it attaches to a protein (CD3) on a T cell, a kind of immune cell. By bringing the T cell close to the cancer cell, it helps the immune system work on the cancer. The Priority Review means that the FDA ..read more