The cancer/oncology space has always been keenly watched by investors interested in the pharma/biotech sector. This is because the disease is one of the leading causes of morbidity and mortality across the world preceded only by heart disease.
Major players in this field include Pfizer (PFE - Free Report) , Bristol-Myers (BMY - Free Report) , Novartis (NVS - Free Report) , AstraZeneca (AZN - Free Report) , Merck (MRK - Free Report) and Roche (RHHBY - Free Report) . Cancer drugs are the most important revenue drivers for these bigwigs as well as their smaller counterparts like Clovis Oncology, Tesaro, and Puma Biotechnology among others
Evolution of the Cancer Space
A lot of progress has been made in this area in the last few years. Companies are aiming to bring out newer and better treatments like immunotherapies, gene therapy, targeted therapy and other novel therapies.
In fact, focus in this area has increased with the FDA approval of CAR-T therapies - Novartis’ Kymriah and Gilead’s (GILD - Free Report) Yescarta - last year. The path-breaking immunocellular therapy is a one-time treatment that uses a patient's own T-cells to fight cancer. The acquisitions of Kite by Gilead and Juno by Celgene have led to renewed interest in this area.
Interest in PARP inhibitors has also increased considerably as they could well be the next major class of therapeutics in oncology.
According to IMSQuintiles, 68 new cancer drugs were approved for 22 indications from 2011 to 2016. Worldwide costs for cancer therapeutics and supportive care drugs shot up from $91 billion in 2012 to $113 billion in 2016 with the United States accounting for 46% of the costs. More than 600 molecules are in late-stage development, with the majority being targeted therapy, which attack a specific feature, or target, in cancer cells.
New Cancer Drugs
New oncology brands including Bristol-Myers’ Opdivo, Merck’s Keytruda, Pfizer’s Ibrance and AbbVie/J&J’s Imbruvica are fast catching up and giving tough competition to category stalwarts such as Avastin, Herceptin, and Rituxan. New cancer drugs approved last year include Pfizer/Merck KGaA’s Bavencio for bladder cancer, Eli Lilly’s Verzenio, Novartis’ Kisqali, Puma Biotechnology’s Nerlynx for breast cancer and Tesaro’s Zejula for ovarian cancer.
The most common indications for new drugs are non-small cell lung cancer (NSCLC), non-Hodgkin’s lymphoma, melanoma, and breast cancer.
Is the Patient Population Benefiting?
It goes without saying that these new drugs bring in millions of bucks for the companies as these are sold for a huge amount of money. However, are these doing enough to cure patients or help them live longer or better? Are these relieving them of pain or fatigue, considering the fact that these come at a premium?
While the FDA has approved a number of oncology drugs in recent years and also lowered the bar for clinical study goals of cancer candidates, the disease still remains the top cause of death in many populations. Here’s probably why.
A few of these drugs have been successful in allowing patients with limited life expectancies to live for years. However, the efficacy of several others is being questioned as they have led to only marginal benefits with not much improvement in survival or quality of life.
Many drugs are being approved based on progression free survival - the amount of time the patients live without their tumors growing larger - without evidence of benefit on survival or quality of life. This is specially the case for drugs that aim to treat terminal cancers with few treatment options. However, overall survival (OS) data, once available, sometimes shows that the drug does not help people live longer. Also, when drugs do offer survival benefits, the gains are often marginal. The risks and long-term side effects of some drugs have also been underestimated.
Overall cancer survival has barely changed over the past decade, which raises concerns about the push to get more drugs approved instead of getting effective drugs approved.