Category: Patient Education

The FDA Priority Review Designation: A Primer

Picture1By Peter Martin, M.D.

Under the Prescription Drug User Act the FDA created a two-tiered system for review of new drug applications (NDA). The first tier of this system, known as Standard Review, is for treatments that offer a minor improvement over existing therapies, and sets the timeline to review at 10 months from receiving the NDA. The second tier, the Priority Review, is for drugs that offer major advances over existing therapies, or provide a treatment where none had previously existed, and reduces the approval timeframe of review to 6 months.

Significant improvements over pre-existing treatments include evidence of increased effectiveness in treatment, prevention, or diagnosis, reduction in treatment-limiting reactions, evidence of safety and effectiveness in a new patient population, and documented enhancement of patient compliance that is thought to lead to an improvement in serious outcomes.

Unlike other expedited approval programs with different levels of standards the Priority Review designation does not change the scientific or medical standards used for approval by the FDA. Instead more resources are devoted to expediting approval for the treatments that receive this designation because the FDA has decided chosen treatments serve a much greater need. To receive the Priority Review designation the FDA requires evidence of increased effectiveness in treatment prevention, or diagnosis of a condition.

Previous Entries in the Primer Series

The FDA Approval Process
The FDA Breakthrough Therapy Designation
THE FDA Accelerated Approval Designation

Lymphoma Physicians Discuss Lenalidomide Plus Rituximab as Initial Mantle Cell Lymphoma Treatment

Recently Dr. John Leonard was interviewed by the Lymphoma Research Foundation and answered questions about the current state of treatment for patients with mantle cell lymphoma (MCL). Specifically, they discussed how results from the 2015, New England Journal of Medicine published study, “Lenalidomide plus Rituximab as Initial Treatment for Mantle Cell Lymphoma” has improved the treatment options for MCL patients. This multi-center phase 2 study showed that a combination therapy, lacking many of the typical debilitating effects of traditional cancer treatment could effectively manage MCL by inducing remissions in the vast majority of patients.

Dr. Leonard, the study’s senior author, described the potential impact of this research and how it could improve our understanding of MCL and treatment as follows,

“This research provides an additional option for patients with MCL and represents the first study of a non-chemotherapy approach that is generally of lower intensity than usual initial treatment. The fact that the majority of patients had durable disease control, with good quality of life, suggests that this approach may have value for some patients. Ongoing research will better assess the longer term outcomes with this approach, and how it either compares with or can be combined with other treatments. This study demonstrates the value of potentially using newer agents as part of initial treatment in MCL, rather than holding off until the disease recurs later.”

In April 2016 the study was nominated by the Clinical Research Forum as one of their Top 10 Clinical Research Achievement Awards of 2016. The 10 winning papers were chosen based on their degree of innovation from a pool of more than 40 nominations from 30 research and academic health centers nationwide.

In the video below you can watch the study’s lead author Dr. Jia Ruan describe the importance of her team’s findings.

10 Tips for Cancer Patients Taking Supplements

Shayne RobinsonBy Shayne Robinson, RD, CSO, CDN

As an oncology dietitian, I always encourage patients to eat a balanced diet of “whole unprocessed foods.” However, there are times when some patients need to use supplements along with conventional treatments in partnership with their physician. Below are 10 tips for cancer patients who have decided to use supplements (after consulting with their healthcare team).

1. Speak up! Report all supplement use to your healthcare team.

2. Have a reason. Patients should only take supplements to prevent a deficiency, manage side effects or co-manage a medical condition.

3. Be informed. Many supplements are metabolized through the same pathway as medications you may be taking. As a result, they may carry a risk for interaction with medication (including oral chemotherapy). Know the evidence to support the supplements you choose, and ask your doctor, registered dietitian and pharmacist about potential interactions.

4. Look over the label – thoroughly. Choose a supplement with the seal of approval from US Pharmacopeia, Consumer Lab, or NSF International to get the best product possible. Make sure you read the fine print and all the disclaimers on the bottle.

5. Ask questions, if your supplement does not provide the expected benefit. There may be significant differences in the quality of various supplements. For example, if you are taking a magnesium supplement for a low magnesium level, and your magnesium level is not increasing, you should question the product.

6. Know your body. Be aware that supplements can be contaminated with drugs, pesticides and heavy metals. If you have an adverse event after starting a new supplement, stop taking it, and report the reaction to your doctor.

7. Be skeptical! If it sounds “too good to be true,” it probably is. “Bad” supplements are sold via multi-level marketing schemes, have exaggerated claims and a price that is often unwarranted.

8. Not all supplements are created equal. Make sure you know exactly what you are getting in your supplement. Supplements stating they are proprietary blends may not disclose how much of each ingredient they contain and may contain sub-par levels of ingredients.

9. Don’t mix and match. Consider the combination of your supplements. If you are taking a multi-vitamin and other supplements containing a nutrient in the multi-vitamin, you may be exceeding the tolerable limit.

10. Supplements aren’t substitutes. Most importantly, remember that a supplement is never a replacement for a healthy diet.

Shayne Robinson, RD CSO CDN is an oncology dietitian formerly with WCM/NYP’s Ambulatory Care Network’s Outpatient Practice. To see a dietitian at our outpatient nutrition practice call (212) 746-0838. Physician referral required.