While we cover the broad spectrum of pharma and biotech pipelines in these pages, there is no doubt cancer is often a dominating theme. That’s not a problem, of course; we cover the news that seems the most compelling and active, and that’s often in the realm of oncology. Heck, it’s why we have a sister site to our main website called “Cancer Research News” at www.ddncancer.com. That said, though, I’m happy to see that this January issue is pretty varied in terms of therapeutic areas covered, even if oncology is still the single biggest representative.
So, I’ll let oncology dominate my “Editor’s Focus” piece right here this month.
Partly this is because I wanted to draw attention to a statement from the American Society of Clinical Oncology (ASCO), in which ASCO President Dr. Julie M. Vose shared news from a report by the American Cancer Society showing a 23-percent decline in cancer death rates between 1991 and 2012 and that estimated an 1.7 million deaths have been averted as a result—with Vose going on to say:
“This 23-percent decline in cancer death rates is the result of decades of advancing our understanding and treatment of cancer. As a result of our nation's investment in cancer research, we have made tremendous progress in prevention, chemotherapy, surgery, radiation, immunotherapy and molecularly targeted treatments. Every cancer survivor is living proof of its progress.
“The cancer community cannot afford to let up on its progress. We must capitalize on opportunities to advance precision medicine, improve patient care through Big Data initiatives and support our nation's federal research infrastructure through robust funding. If we can meet those needs as a nation, we will continue to see the type of progress highlighted in this report.”
The other reason I wanted to let oncology come out to play in my editorial is because one of our cover articles this month, “FDA beats the averages on approvals,” spends a lot of time talking about how much approval activity had to do with rare diseases, and I didn’t have room in the article to talk about some of the other areas, like cancer.
The FDA noted of 2015 that 16 of the 45 novel new drugs approved in 2015—more than one-third—were designated as first in class. The FDA took a moment to recognize three such drugs it saw as particularly notable, and one of them was Ibrance for the treatment of advanced (metastatic) breast cancer. The other two “noteworthy” drugs were Bridion to reverse post-surgical neuromuscular blockade caused by certain kinds of anesthesia and Praxbind to reverse adverse anticoagulant effects caused by the blood-thinner drug dabigatran.
In addition to the first-in-class and orphan new products, the FDA also called noteworthy the new novel cancer therapies Darzalex, Empliciti, Farydak and Ninlaro to treat patients with multiple myeloma, Alecensa and Tagrisso to treat certain patients with non-small cell lung cancer, Cotellic to treat certain patients with metastatic melanoma, Lonsurf for the treatment of certain patients with metastatic colorectal cancer and Yondelis for treatment of soft tissue carcinoma.
And, oh...I can’t help it. Journalistic instincts scream out to balance the scales...
The FDA also cited as noteworthy such 2015-approved novel new drugs as Avycaz, to treat complicated intra-abdominal infections and complicated urinary tract infections, and the antifungal product Cresemba, to treat invasive aspergillosis and invasive mucormycosis, rare but serious infections. Also notable were the heart drugs Entresto to treat heart failure and Corlanor to reduce hospitalization from worsening heart failure, and the hypercholesterolemia treatments Praluent to treat certain patients with hard-to-treat heterozygous familiar hypercholesterolemia and Repatha to treat this same condition as well as homozygous familial hypercholesterolemia. In addition, Viberzi to treat patients who have irritable bowel syndrome with diarrhea, Veltassa to treat hyperkalemia and Daklinza to treat chronic hepatitis C virus genotype 3 infections.
Now, at the risk of making this edition of “Editor’s Focus” simply a roundup, let me share some of my own thoughts.
First, it’s great to see such progress in the fight against cancer, both from the research and development front and the regulatory approval front. I imagine cancer will continue to be one of the top killers of people worldwide long past my own demise (hopefully a few decades away, at least), but seeing it get knocked down the list a bit would be good. All forms of death are disheartening, but I think I’d rather see more of them be from lifestyle choices or accidents than from our bodies’ own cells becoming a runaway proliferation train.
Second, I’m pleased to see such progress with approvals at FDA. There have been times in the past I’ve skewered them for sluggish approval rates, but the 2015 news is encouraging both in terms of rare diseases and novel new therapies in general. Here’s hoping that even if we do continue to underfund the FDA (and let’s cut that out, shall we, as well as properly funding NIH) that it can keep the momentum going.