27 posts tagged “FDA”

2 immunotherapy treatments in the news: Imfinzi and Keytruda update

Posted 4 months ago by

Two immunotherapy treatments — Imfinzi (durvalumab) and Keytruda (pembrolizumab) — have made headlines recently in relation to lung cancer treatment. What’s the latest? Here’s an update.

Expanded FDA approval for Imfinzi

The U.S. Food and Drug Administration (FDA) first approved Imfinzi as a bladder cancer treatment in 2017. Imfinzi is marketed by AstraZeneca.

In February 2018, the FDA approved Imfinzi for some lung cancer cases — specifically for patients with “stage 3 non-small cell lung cancer [NSCLC] who are not able to be treated with surgery to remove their tumor, and whose cancer has not gotten worse after they received chemotherapy along with radiation (chemoradiation),” the American Cancer Society (ACS) explains.

A few more details on Imfinzi, according to the ACS:

  • The goal of treatment with this drug is to keep the cancer from getting worse for as long as possible (researchers call this “progression-free survival”).
  • The new approval for Imfinzi was based on a randomized clinical trial of 713 people, which found that those who received the drug had an average progression-free survival of 16.8 months compared to 5.6 months for those in the trial who did not receive it.
  • Imfinzi is a “checkpoint inhibitor” drug that targets and blocks the PD-L1 protein to help the immune system recognize and attack cancer cells (learn more about PD-L1 here, and read about possible Imfinzi side effects here)

The new approval for Imfinzi applies to very specific cases of NSCLC, but Reuters says it represents “a chance to intervene earlier in lung cancer,” since other approved immunotherapy treatments are tackling advanced or metastatic cancer.

Positive research on Keytruda + chemotherapy

Keytruda is another “checkpoint inhibitor” immunotherapy treatment that’s already on the market but making big headlines, thanks to new clinical trial findings.

Research published this month in the New England Journal of Medicine shows that Keytruda is useful in combination with standard chemotherapy in the majority of patients diagnosed with an advanced form of lung cancer — specifically those with previously untreated metastatic nonsquamous NSCLC without EGFR or ALK gene mutations.

“Doctors already prescribe Keytruda to patients if a lab test shows that they are likely to respond to this drug,” NPR reports. “But Merck, the company that makes it, wanted to find out how the drug works in patients who aren’t obvious candidates as determined by that blood test… It turns out that Keytruda, in combination with standard chemotherapy, also works in patients even if they have a low score on the lab test, which measures something called the tumor proportion score for PD-L1.”

The phase 2 clinical trial involved 616 patients with advanced lung cancer from medical centers in 16 countries (check out this PatientsLikeMe guide to clinical trials and drug approvals).

“The findings, medical experts say, should change the way doctors treat lung cancer: Patients with this form of the disease should receive immunotherapy as early as possible,” The New York Times reports, along with more details on the research.

Check out PatientsLikeMe member’s treatment evaluations of Keytruda (pembrolizumab) here (become a member for access to more information). And see our previous round-up on lung cancer research and treatments (with many studies still ongoing).

Full disclosure: PatientsLikeMe is currently partnering with AstraZeneca on research projects. We’ve also partnered with Merck in the past. The article above is not sponsored – this topic has made headlines lately and we like to share relevant health news to help keep our communities informed. Questions about our partnerships? At PatientsLikeMe, we’re all about transparency so check out who we’ve worked with here.

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5 Earth-friendly ideas for patients

Posted 5 months ago by

As Earth Month winds down, explore some environmental pointers, including how to donate (gently used) wheelchairs, what to do with empty pill bottles (earbud/jewelry case, anyone?) and where to dispose of unused meds (April 28, 2018, happens to be National Prescription Drug Takeback Day at 5,000+ sites across the U.S… read on!).

1. Donate unused medical supplies. Before adding unused supplies or gently used equipment to your trash heap, see if they’re on the wishlist of organizations that accept medical surplus, such as InterVolMedshare and Project C.U.R.E. (click to see lists of what they’ll take).

InterVol’s general rules of thumb for donations?

  • Would you want the item/supplies used on you?
  • Does it have one year left before the expiration date, if it goes in the body?
  • Does the equipment function as intended (no broken or missing parts)?
  • Is the equipment in good shape (no rust, rips, tears, etc.)?

2. (Properly) hand over unused medications. Few organizations accept prescription drug donations from individuals, and drug donation and redistribution laws vary by state. Look into the regulations where you live and comment below if you know of any organizations that accept donated medications (such as Insulin for Life, which collects some insulin and diabetes supplies).

Note: This Saturday is National Prescription Drug Takeback Day (April 28, 2018, from 10 a.m. to 2 p.m.), sponsored by the U.S. Drug Enforcement Administration twice a year so that people can bring unused or expired medications to a local collection site for safe disposal (search for a site near you). In the last Takeback Day in October 2017, people dropped off 456 tons of drugs.

3. Safely dispose of unused drugs and medical waste on your own. Cancer.net offers these pointers for medication disposal: “If you decide to take the matter into your own hands, you should always follow the disposal instructions found on the drug label or the patient information leaflet that comes with the prescription. Do not flush medicines down the toilet or sink unless this information specifically tells you to.”

The U.S. Food and Drug Administration lists the few medications that should be flushed— but check with your local water treatment and/or sanitation department about any rules or regulations.

The U.S. Environmental Protection Agency offers this info on proper disposal of discarded needles, sharps and other medical waste. Wondering what to do with old oxygen tanks? See this guide.

4. Find new uses for empty pill bottles. An Indianapolis-based charity called The Malawi Project organized a hugely successful pill bottle collection drive to send the ubiquitous orange containers to the African country hit hard by HIV (where people were carrying their pills loose or wrapped in paper). After a million pill bottles quickly poured in, the organization stopped accepting donations — but they still encourage people look into other organizations still collecting them, or contact local animal shelters to see if they need them.

Recycle Nation says that few communities accept the orange (#5 plastic) pill bottles in their recycling programs, but a company called Preserve collects them at natural food stores across the country (check out this map) to use in their recycled plastic products. CVS Pharmacy is reportedly working on pill bottle recycling programs.

People have come up with lots of other creative ways to reuse or upcycle pill bottles — just a few neat ideas include:

  • “Hide-a-key” container (with a rock glued on top)
  • Earbud/headphone holder
  • Jewelry case
  • Mini sewing kit
  • Child-proof storage for quarters (for parking or laundry), pins, nails/screws, medical sharps or other small items

5. Go paperless with your insurance company and doctor’s office. Opt for electronic communication, if you’re comfortable with it. Many providers now offer email and/or text reminders rather than snail mail postcards or phone calls. Also, hospital gowns can be a drag for patients, and the paper ones contribute to medical waste. Depending on the medical setting and type of visit, ask your healthcare provider if it’s necessary to fully undress and wear a gown or use other (optional) disposable items for your visit.

Happy Earth Month!

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