4 posts tagged “drug information”

2 immunotherapy treatments in the news: Imfinzi and Keytruda update

Posted May 10th, 2018 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.

Looking for more information on patients’ experiences and treatments for lung cancer? Join PatientsLikeMe today to connect with 9,000+ members with lung cancer.

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Want to know more about Radicava (edaravone)? Here’s a snapshot:

Posted August 17th, 2017 by

With the recent FDA approval of Radicava (edaravone), we wanted to know more about how it works and what it means for patients living with ALS. We asked Maria Lowe, Pharm.D., BCPS, and our Health Data Integrity team, to give us a snapshot of the drug, how it’s used and what you should know. Maria’s rundown is meant to give you more context so you can have better conversations with your care team – as always, talk with your physician before starting any type of new treatment.

Radicava: The quick hits

  • Radicava works as a free radical scavenger.
  • When free radical (toxic by-products of cells that are highly unstable and reactive) levels are too high, cells are damaged resulting in oxidative stress (which may damage motor neurons). The way in which Radicava works to help patients with ALS is not fully understood yet; however, researchers believe that by getting rid of these free radicals it can help prevent some cell damage.
  • In clinical trials, treatment with Radicava was found to slow the decline in functional disability as measured by ALSFRS-r scores for some patients. However, it is important to note that Radicava does not stop the death of motor neurons (it’s not a cure).
  • Radicava may be taken in conjunction with riluzole (consult healthcare provider).
  • Radicava is administered intravenously (60 mg IV over 60 min) daily for 14 days, followed by a 14-day drug-free period. Subsequent cycles are administered daily for 10 days over a 14-day period followed by 14-day drug-free periods. Because this drug is meant for long term use, patients will need to have a peripherally inserted central catheter (PICC line) or some other kind of catheter installed.

Clinical trials and FDA approval

  • FDA approval for Radicava was based on a Phase III clinical trial conducted in Japan only in Japanese patients. Patients enrolled had to have ALS for less than two years, have normal respiratory function as well as the ability to complete most activities of daily living.
    • Radicava may be processed and function differently in different patient populations. Post marketing data will be important for determining the effects and impact of the drug in patients other than those who participated in the clinical trials.

Side effects and reactions:

  • The most common side effects reported in clinical trials include bruising, problems walking (gait disturbance), and headache.
  • Hypersensitivity reactions:  Radicava may cause allergic reactions that could happen after the infusion has finished.
    • Symptoms to watch for: Hives, swelling, dizziness, wheezing, shortness of breath, itching, and fainting.
    • If you’ve experience allergies to other medications before, inform your healthcare provider.
  • Sulfite allergic reactions: Since Radicava includes sodium bisulfite as an ingredient, those with sulfite allergies should be cautious when taking this drug.
    • Those with asthma have a higher risk of developing sulfite sensitivity. Let your healthcare provider know if you have asthma.
    • Symptoms to watch for: Hives, trouble breathing/ swallowing, itching, swelling, dizziness, asthma attacks (in people with asthma), wheezing and fainting.
    • If you have a sulfa allergy, you may or may not have a reaction to this drug. Sulfa allergies are a result of hypersensitivity to a chemical structure called sulfonamides, which are common in many antibiotics. Sulfites are chemically different from sulfonamides and any reaction to sulfites is not related to sensitivity to sulfa drugs. Both can cause reactions, but they are not related.
  • If you are pregnant or plan on becoming pregnant and/or are breastfeeding, let your healthcare provider know. It is not known if Radicava will harm the baby or if it passes into breast milk.

Availability and access

  • Radicava is expected to be available in August of this year as a brand name drug and it’s estimated it will cost around $145,000 per year in out of pocket costs (does not account for insurance coverage).
  • Because the drug isn’t available yet, many insurance companies may not have developed policies regarding coverage. Different insurance programs will develop such policies of coverage of new drugs at different times.
  • MT Pharma America (MTPA), the manufacturing company for Radicava, has developed a program called Searchlight Support to help people with ALS learn more about this treatment and to help them find and secure coverage through their insurance.
    • Searchlight Support offers out of pocket support options only to certain eligible patients with commercial insurance. Patients with Medicaid, Medicare and other government funded insurance may not qualify.

Interested in learning more about whether Radicava is right for you?

Check out the medication guide and contact the Searchlight Support program to learn more about the potential financial support programs and to find an infusion center near you.

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Disclaimer: At PatientsLikeMe, we’re all about transparency, so please keep in mind that this piece is solely to provide a snapshot of Radicava so you can stay informed and make better decisions with your care team. This content isn’t sponsored and we don’t have a financial relationship with the drug manufacturer.