The first drug approved to treat BRCA-related breast cancer has limits, but it’s important for women with metastatic disease and BRCA mutation carriers.
There’s a new drug to treat one of the tougher types of breast cancer.
It’ll buy you about three extra months of what’s called progression-free survival.
And it’ll cost you, or your insurance company, $13,000 a month.
Is it worth it?
Experts interviewed by Healthline seem to think that for most people, it probably is. They also see a lot of potential for this kind of drug in the future.
Earlier this month, the Food and Drug Administration (FDA) approved the first treatment specifically for advanced breast cancer associated with BRCA gene mutations.
The drug, Lynparza, is already used to treat ovarian cancer.
Its expanded use now includes HER2-negative metastatic breast cancer in women who carry BRCA gene mutations.
Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor. It blocks an enzyme that helps repair damaged DNA, making cancerous cells with damaged BRCA genes less likely to be repaired.
This can slow or stop tumor growth.
The National Cancer Institute estimated there were 252,710 new cases of female breast cancer and 40,610 deaths from the disease in the United States last year.
BRCA1 and BRCA2 mutations make up about 5 to 10 percent of all breast cancers. BRCA mutations are also associated with ovarian, fallopian tube, peritoneal, prostate, and pancreatic cancers.
You can inherit BRCA gene mutations from either parent. If one parent carries the mutation, their children have a 50 percent chance of inheriting it.
Approval of Lynparza was granted to AstraZeneca Pharmaceuticals LP.
Who can take Lynparza
The new approval for Lynparza is for women who have already had some chemotherapy or hormone therapy.
Dr. Jack Jacoub is a medical oncologist and medical director of MemorialCare Cancer Institute at Orange Coast Medical Center in California.
Jacoub told Healthline that the length of prior chemotherapy is variable.
“Someone could have been on chemotherapy a year or two, then progressed. Then the clinician tried something else they felt should be stopped. It could happen quickly or she could have been on chemo for some time. It depends on response to treatment,” he explained.
“Some women might continue to take hormone therapies,” continued Jacoub. “There are some nuances to that. BRCA1 is almost associated with triple-negative breast cancer. But in the BRCA2 group, the majority is estrogen receptor-positive and would continue on hormone therapy along with this drug. But with some patients on chemotherapy, when they’ve reached that point, clinicians often feel they’ve exhausted the benefits of hormone therapy drugs. Each patient is different,” said Jacoub.
FDA approval for a blood test called BRACAnalysis CDx has been granted to Myriad Genetic Laboratories, Inc. The test determines eligibility for the treatment.
Progression-free survival and quality of life
Progression-free survival is the length of time tumors don’t show significant growth after treatment.
In trials, median progression-free survival for patients taking Lynparza was seven months. For patients on chemotherapy alone, it was slightly more than four months.
For Josh Newby, Komen Advocate in Science for Susan G. Komen, it’s personal.
He lost his mother to metastatic breast cancer associated with the BRCA2 gene mutation.
“Progression-free survival is an interesting phrase,” Newby said in an interview with Healthline.
“As patients and advocates, we want to look at things other than that. My mother, who was not doing very well, got on a drug that extended her life by five months. But extension of life with quality of life is important. Before she passed away, my mother was able to travel and see and do things,” said Newby.
Jacoub agreed that length of survival isn’t the only thing to consider.
“Metastatic disease obviously implies that it’s incurable. So, a woman’s survival duration is important, but so is quality of life. If giving one therapy would make someone absolutely miserable, you’d have to really think hard about how much you’re helping. But if it’s tolerable, by all means. You build these blocks of time,” said Jacoub.
The FDA lists a variety of common side effects, including low red or white blood cell counts, nausea, and respiratory tract infections. Severe side effects include cancers of the blood or bone marrow, and inflammation in the lungs.
Jacoub said the discussion of side effects is important for many reasons.
They vary from person to person. And there’s a learning curve with its use.
“We see it in women with ovarian cancer. Side effects can become impressive in the first few weeks. Don’t trivialize them because it’s a pill and not an IV drug. This class of drugs carries its own set of side effects that can be fairly substantial and that one has to respect and be careful of. They can be similar or worse than IV chemo, depending on the agent used,” cautioned Jacoub.
“There are symptoms from the disease. Shrinking a tumor is important. There’s a meaningful benefit in the setting of metastatic disease,” he said.
About the seven-month progression-free survival in the trial, Jacoub pointed out that while half didn’t do as well, half did a whole lot better.
“There’s no exact mathematical model. So there are situations where you can have a fairly satisfying response. I wouldn’t cite long-lasting response as the reason to do it. Hope is important, but you have to frame it in realistic boundaries,” he continued.
Heavy price tag
Without insurance, Lynparza costs $13,886 per month.
Addressing the cost of the drug, Jacoub said, “Insurance is obligated to cover it. The cost, honestly, is overwhelming and there’s no question it’s a burden.”
He noted that the price is comparable to other special oral drugs in this area.
“Some oral targeted drugs can be taken for years in some diseases. It takes a lot of money and effort to develop these drugs, but if you see others coming out, there may be some cost competition. Often times the cost doesn’t really decrease until the drug is out of patent. We’re eager to have more tools to help patients and it’s a good discussion to have,” said Jacoub.
There are challenges for those who don’t have insurance.
“Reach out to organizations like Komen and others who provide support and guidance,” suggested Newby. “And I can’t stress enough how important it is to get a second opinion, even if you’re at one of the top cancer centers in the world. Different institutions have different abilities to navigate insurance or find compassionate use.”
AstraZeneca offers some assistance with copays and out-of-pocket costs.
Research moving into a new realm
Lynparza is the first PARP inhibitor approved for breast cancer.
It’s also the first time a drug has been approved to treat metastatic breast cancer associated with BRCA gene mutations.
Jacoub hopes it’s the first in a line of new PARP inhibitors for breast cancer treatment.
“This class of drugs is being studied across multiple phases of disease, including in a preoperative setting. The metastatic setting is the fertile soil from which we get these questions. We always want to take it into earlier-stage settings. It’s the first clear sign there is a benefit. I suspect it will be joined by others,” he said.
Jacoub said the field of BRCA cancers and other hereditary cancers is a fast-moving area. He expects things to be changing a lot.
“People were talking about this even before the application was submitted to the FDA,” said Newby.
“Not only because of the results, but because of the way researchers are looking at cancer. What we’ve learned is that we need to study each patient’s individual cancer based on genetic mutation, not just tumor type. What’s interesting is that since the approval there’s been a buzz. This is getting attention from the general public. We’re moving into a new realm,” he continued.
“The next step is to identify those patients who will be exceptional responders to new drugs being approved. Not only will you probably see this drug applied to other tumor types, but companies are working on similar drugs. Organizations like Komen and others want to fund the kind of research that gets the wheels spinning. This moves the research forward,” said Newby.
Awareness, advocacy, and hope
Jacoub encourages patients to keep up on developments and discuss them with their oncologists.
And Newby promotes self-advocacy.
“My mom passed away four years ago and about five drugs have since been approved for metastatic breast cancer. That’s pretty amazing,” said Newby.
“Each cancer is unique in its own way, not only from a scientific molecular level, but on a personal level,” he said.
Newby is a BRCA2 gene mutation carrier.
He hopes to have children someday. Those children would have a 50-50 chance of carrying the same mutation.
“Hopefully, that will change and my children won’t have to face this same kind of problem. The key is to create awareness about drugs being approved. It’s not a cure, but it’s moving in that direction with support from organizations like Komen that are working with patients. Again, I can’t stress enough: Be your own advocate, or advocate for a loved one. Get tested and seek out help and counseling. There are many resources out there,” said Newby.