There has been a wave of new FDA approved drugs targeted towards cancer patients so far this year, but as the coronavirus pandemic halts current research, future approvals may be in jeopardy
Published May 29, 2020
The record pace of new cancer drugs approval and new indications receiving approval by the FDA could be in danger as COVID-19 dramatically reduces the number of clinical trials available to patients.
The extraordinary wave of drug approvals for cancer is being driven by factors including a scientific revolution in genomics and immunotherapy, willingness from companies and investors to fund research, and a newly sped up FDA approval process.
“The data tends to show that we’ve had a number of [new] cancer approvals, [but] it’ll be interesting to see if this trend holds true later this year and next year because of COVID-19,” says Dr. Otis Brawley, a medical oncologist and epidemiologist at John Hopkins University and Bloomberg distinguished professor.
During the first months of 2020, the Food and Drug Administration (FDA) has approved treatments such as aggressive lung cancer drug Tabrecta, PARP Inhibitor Olaparib for advanced prostate cancer, daratumumab for newly diagnosed or recurring multiple myeloma, and others. Since January, fourteen cancer drugs have been approved by the FDA, with many serving as frontline treatment. In 2017, there were a wave of cancer drug approvals totaling 27 in oncology and hematology, and in 2018, the FDA approved 19 completely new cancer drugs.
While the number of approvals in 2020 so far points to promising treatment options for cancer patients, cancer researchers tell SurvivorNet that these approvals stem from research conducted prior to COVID-19, with some clinical trials occurring at the end of 2019. So, as many clinical trials have been halted entirely due to the outbreak, there’s a chance future drug approvals may slow down later this year.
“We’ve shut down at Hopkins as has most other big places that do clinical trials, and we’re starting to open up again,” Dr. Brawley says. “The approvals from the FDA we’re seeing is based on data submitted to the FDA earlier this year and sometimes even late last year. I’ll bet some things that were approved in the last month were from clinical trials where some of them ended the year before last. So if your drug company has done clinical trials and registration trials to get your drug approved, you’ll finish that trial and usually spend six months to a year crunching the data, making observations about it, trying to learn as much as you possibly can before you make an [FDA] submission. So, the COVID-19 effect that’s impacted trials over the last few months is something we might very well see next year.”
Another concern facing future cancer research is the number of researchers who will be present after COVID-19. Due to many medical teams diverting their focus into coronavirus patients, Dr. Brawley says he’s worried that members of clinical trial teams will decrease due to the demand brought on by the outbreak.
“My biggest concern I have with COVID-19 is there are some really gifted laboratory scientists who were doing cancer work and now are doing coronavirus work,” Dr. Brawley says. “Somewhere between 5-10% of really talented people who, in February, were doing cancer research are now doing coronavirus research, and will continue doing coronavirus research in the future. I’m worried that we’re going to lose those people from cancer forever.”
In March, the FDA announced a new program which accelerates drug approvals in an effort to increase access to possible coronavirus treatments. Through this program, the FDA will review data to new clinical trials within 24 hours, and turn around single-patient requests for expanded access to certain therapies “within three hours.” In short, the FDA is reviewing new drug applications and clinical trial results faster than ever before. While searching for COVID-19 treatments, some cancer drugs have been tested to see whether they are benefitting patients.
Selinexor, a drug taken orally for the treatment of reoccurring multiple myeloma, was developed by Dr. Sharon Shacham, Karyopharm’s Chief Scientific Officer. Karyopharm’s CEO, Dr. Michael Kauffman, told SurvivorNet in a separate interview that the trials using low doses of Selinexor as a treatment for people with Covid-19 are progressing and now in phase two. The drug targets Exportin-1 protein, which is needed in order for a virus to spread within the body and drives inflammatory responses. This could potentially make it more difficult for COVID-19 to spread across the body and infect other cells. Additionally, Selinexor helps block inflammatory responses to the virus which will help people’s lungs function better and possibly prevent patients from going on ventilators.
These new drug approvals mark significant progress towards cancer treatment, but it takes months before they are fully accessible to patients. According to Dr. Brawley, following an FDA approval of a drug, it takes six months before the drug is readily available to patients, and immediate access to a recently approved FDA drug is relatively rare in most cases. However, Dr. Brawley says that in some cases it has happened.
Overall accessibility to recently approved drugs also concerns socioeconomic disparities within communities. In rural Southern states, particularly Appalachian areas, accessibility to cancer treatment and drug access is disproportionate compared to other areas.
It’s still difficult for patients to enroll in clinical trials, and due to COVID-19, it’s even more challenging. That’s why it’s never been more important patients visit clinicaltrials.gov to see which existing trials are open, and are proactive in pushing their doctors for more information in order to educate themselves as much as possible.
The rate of cancer-related in the United States saw the largest ever single-year drop between 2016 and 2017, as the rate of cancer deaths dropped by 2.2% over a single year period, with the sharpest decline in lung cancer. In addition to the recent decline, over the past three decades, there has been a remarkable decline in cancer deaths. Since 1991, there has been an approximate of 2.9 million fewer cancer deaths, as the rate as the mortality rate has dropped 29%.
This is largely thanks to immunotherapy drugs, a relatively new treatment option which uses the body’s own immune system to attack the cancer. Immunotherapy, for lung cancer in particular, uses checkpoint inhibitors. Checkpoint inhibitors are man-made antibodies that shut down key proteins on immune cells such as PD-L1 that, when turned on, can give cancer a free pass to spread. Given intravenously, these immunotherapy drugs essentially wake up the immune system and encourage it to recognize the protein and attack it. Because these drugs are aimed at a specific target, there are fewer side effects than chemotherapy.