Imfinzi approved in the EU for the treatment of advanced small cell lung cancer (2023)

FAQs

Is Imfinzi approved in EU? ›

AstraZeneca's Imfinzi (durvalumab) has been approved in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).

Imfinzi is approved in the US and several other countries in combination with chemotherapy for the treatment of locally advanced or metastatic biliary tract cancer based on the TOPAZ-1 Phase III trial, and it is approved with Imjudo in the US for the treatment of unresectable hepatocellular carcinoma based on the ...

Immunotherapy is a newer form of treatment for stage 3 lung cancer, but it's showing promise as an effective solution for dealing with this disease. While it isn't right for everyone, immunotherapy may allow you to use your own body to help fight your cancer.

Imfinzi contains the active ingredient durvalumab. Keytruda contains a different active ingredient, pembrolizumab.

With IMFINZI, 43% of patients were still alive at the 5-year landmark.

No. In general, Medicare prescription drug plans (Part D) do not cover this drug.

ABOUT IMFINZI

IMFINZI is an immunotherapy—not chemotherapy. That means it works with the immune system to find and attack cancer. IMFINZI may also attack healthy cells. If chemoradiation therapy (CRT) has worked for you, IMFINZI may be your next step.

Patients will receive IMFINZI every 2 weeks or every 4 weeks for up to 12 months or until the disease has worsened or side effects become intolerable. Your doctor will decide how long you will receive IMFINZI and how many treatments you need.

Immunotherapy drugs called checkpoint inhibitors have given many lung cancer patients a lifesaving new option. But patients with small cell lung cancer have seen little benefit from the new paradigm.

Does Imfinzi work for SCLC? ›

Imfinzi is approved for the 1st-line treatment of ES-SCLC in combination with SoC chemotherapy in the US and Singapore. Imfinzi is also approved for previously treated patients with advanced bladder cancer in the US and a small number of other countries.

Though stage 3 lung cancer is generally not considered curable, it is treatable. With the development of new and promising lung cancer treatments, more people may have a chance of achieving remission than ever before.

In her study, 70% of the patients who were able to complete 2 years on the chemo-immunotherapy combination were still alive at five years. They get infusions every three weeks for those two years, but most can work during treatment. "The quality of life of these patients is quite high," Garassino said.

Summary. Currently, there is no cure for stage 3 lung cancers, but treatment can often help prolong life and relieve symptoms. In some cases, a person with stage 3 lung cancer may survive another 5 years or longer .

Durvalumab is the generic name for the trade name drug, Imfinzi. In some cases, health care professionals may use the trade name, Imfinzi, when referring to the generic drug name, durvalumab.

You usually have durvalumab every 2 weeks. It takes about an hour each time you have it. You have durvalumab for as long as it works and the side effects are not too bad. You usually have it for up to a year.

Data suggest that stopping immunotherapy after 1 year of treatment could lead to inferior progression-free survival and overall survival, says Lopes. However, stopping after 2 years does not appear to negatively impact survival.

A study conducted by UCLA researchers involving patients with non-small cell lung cancer (NSCLC) found that the immunotherapy drug pembrolizumab increased the average 5-year survival rate of these patients from 5.5% to 15%.

⁶ Of the trial participants who received the combination therapy, 49% were still alive after six and a half years, with 34% experiencing progression-free survival. The median survival for those who received combination therapy was 72.1 months. 1.

Can immunotherapy help you live longer? ›

Patients receiving the immunotherapy drug combination had a median overall survival of 14.5 months, compared with 11.6 months for patients receiving standard of care therapy.

Do health insurance plans pay for immunotherapy? Many private insurance plans, including Medicare Advantage plans, cover cancer immunotherapy. So does Medicare. These plans also may cover other types of immunotherapy.

If you receive immunotherapy as an inpatient, the hospital costs related to your immunotherapy are typically covered by Medicare Part A (Hospital Insurance). If you receive immunotherapy as an outpatient, your doctor's services are covered by Medicare Part B (Medical Insurance).

IMFINZI is indicated for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Both immunotherapy and chemotherapy can be effective cancer treatments. One is not better than the other. The effectiveness of each treatment depends on the type and stage of cancer a person has.

Immunotherapy, in general, is less toxic than chemotherapy for patients with cancer. However, the side effects [adverse events (AE)] linked to these new treatments [treatment-related adverse events (trAEs)] are often described and have variable severity (6).

Currently, there's no designated end to immunotherapy treatment. You may continue on the regimen as long as you continue to have a good response. Patients sometimes ask to take a break from treatment.

Updated OS and PFS remained consistent with the primary analyses; of patients randomly assigned to durvalumab, an estimated 42.9% remain alive at 5 years and 33.1% remain alive and progression-free.

Imfinzi is approved in the curative-intent setting of unresectable, Stage III NSCLC after CRT in the US, Japan, China, across the EU and in many other countries. Since the first approval in February 2018, more than 80,000 patients in this setting have been treated with Imfinzi.

How long does SCLC stay in remission? ›

However, remission lasts less than a year in most cases. Few cases are cured. Some doctors consider your cancer cured if your remission last more than 5 years . In a 2020 study, researchers found that more than 90 percent of cases of small-cell lung cancer came back within 2 years.

If left untreated, patients with SCLC rarely survive longer than a few months 5, but chemotherapy dramatically prolongs survival compared to the best supportive care 6. For patients with ES-SCLC, 60–80% respond to chemotherapy, although complete remission is observed in only 15–20%.

SCLC exhibits faster disease progression and poorer prognosis than other types of lung cancer. SCLC is highly sensitive to initial chemotherapy and radiation therapy, but most patients eventually die of recurrent disease. Here, we report a rare case of complete spontaneous remission in an elderly patient with SCLC.

IMFINZI can cause serious side effects (see above):

The most common side effects of IMFINZI when used with other anticancer medicines in people with ES-SCLC include nausea, hair loss, and feeling tired or weak. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These updated exploratory analyses demonstrate durable PFS and sustained OS benefit with durvalumab after chemoradiotherapy. An estimated 49.6% of patients randomized to durvalumab remain alive at 4 years (placebo, 36.3%), and 35.3% remain alive and progression-free (placebo, 19.5%).

The outlook for NSCLC is better than SCLC. Most people find out they have SCLC when it's already spread to other parts of their body. Early detection helps, but it's often found late because you may not have symptoms. With SCLC, the 5-year survival rate is less than 5%.

Research has shown that durvalumab can slow tumor growth and shrink tumors in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma.

Many people stay on immunotherapy for up to two years. Checkpoint inhibitors can take weeks or months to start working, depending on how your immune system and the cancer respond. Most cancers have treatment protocols that set out which drugs to have, how much and how often.

THE MOST COMMON SIDE EFFECTS OF IMFINZI IN PEOPLE WITH UNRESECTABLE STAGE 3 NSCLC INCLUDE: Cough. Feeling tired. Inflammation in the lungs.

Amivantamab is the first approved treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for NSCLC.

Is durvalumab approved? ›

On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal ...

Currently the compound is only available in Canada and the US or for those involved in the trial being carried out by Amylyx. The Phase 3 PHOENIX study is currently the only route to access AMX0035 in Europe.

European Medicines Agency (EMA) : EMA is a decentralized body of the European Union, located in Amsterdam in the Netherlands. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the EU.

The European Commission is the authorising body for all centrally authorised product, who takes a legally binding decision based on EMA's recommendation. This decision is issued within 67 days of receipt of EMA's recommendation.

IMFINZI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time.

Imfinzi belongs to a class of drugs called PD-1/PD-L1 Inhibitors.