Bavencio (avelumab)

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Bavencio (avelumab)

Bavencio (avelumab) is a medication used for the treatment of metastatic Merkel cell carcinoma (MCC) and locally advanced or metastatic urothelial carcinoma.

How to buy Bavencio (avelumab): You can order Bavencio (avelumab) from TheSocialMedwork if the drug has not been approved or is not available in your country. 

Oncology Urothelial Carcinoma, Skin Cancer
Marketing Authorisation Holder Merck Serono Europe Limited
Mode of Action PD-L1 blocking antibody (immunotherapy)
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 20 milligram / millilitre
Package 1 vial of 200 mg / 10 ml - Vials

What is Bavencio (avelumab) for?

Bavencio (avelumab) is an immunotherapy (a programmed death ligand-1 (PD-L1) blocking antibody) indicated for the treatment of people with metastatic Merkel cell carcinoma (MCC)1,3,6 (a rare type of skin cancer) and adult patients with locally advanced or metastatic urothelial carcinoma1 (cancer of the bladder and urinary system).

How does Bavencio (avelumab) work?

Bavencio (avelumab) targets the PD-1/PD-L1 pathway2 which is involved in the regulation of the immune system. PD-1 (programmed cell death-1) is a receptor, while PD-L1 (programmed death ligand-1) is a ligand that binds to the PD-1 receptor and ensures that immune responses occur only at the appropriate time5. PD-1 receptors are found on certain cells of the immune system called T cells. PD-L1 and PD-L2 are proteins normally found on certain cells of the immune system and can be produced by certain cancer cells. PD-L1 and PD-L2 can attach to the PD-1 receptors, switching off the T cells. Bavencio (avelumab) attaches to the PD-1 receptors on T-cells and thus impedes the binding of the cancer cell with the T-cell via PD-L1 and PD-L2 ligands. In this way, Bavencio (avelumab) prevents cancer cells from switching off T cells and increases the ability of the immune system to kill cancer cells1.

Where has Bavencio (avelumab) been approved?

Bavencio (avelumab) was approved by:

  • Food and Drug Administration (FDA), USA:

    • March 23, 20171 with an accelerated approval for people over the age of 12 with metastatic Merkel cell carcinoma (MCC)

    • October 12, 20171 with an accelerated approval for adults with locally advanced or metastatic urothelial carcinoma

  • European Medical Agency (EMA), European Union, September 18, 20174, with a conditional approval for adult patients with metastatic Merkel cell carcinoma (MCC)

  • Therapeutic Goods Administration (TGA), Australia, January 3, 20186 for people over the age of 12 with metastatic Merkel cell carcinoma (MCC).

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Bavencio (avelumab) taken?

The standard dosage is:

  • 10 mg/kg (milligram per kilogram of body weight) as an intravenous infusion over 60 minutes every 2 weeks1,3.

Premedicate for the first 4 infusions and subsequently as needed.

Complete information about Bavencio (avelumab) dosage and administration can be found in the official prescribing information listed in our resources section1,3.

Note: Please consult your treating doctor for personalised dosing.

Are there any known side effects adverse reactions of Bavencio (avelumab)?

Listed here are the most common side effects outlined in the side effects data resulting from clinical studies. For a personal discussion about the potential reactions of this medicine please contact one of our qualified pharmacists in our support team.

Common side effects

Merkel cell carcinoma

The most common side effects (≥ 20%) listed in the prescribing information include1,3:

  • fatigue (tiredness)

  • musculoskeletal pain

  • diarrhea

  • nausea (feeling sick)

  • infusion-related reaction

  • rash (skin reaction)

  • decreased appetite

  • peripheral edema (accumulation of fluid)

  • constipation.

Urothelial carcinoma

The most common side effects (≥ 20%) listed in the prescribing information include1:

  • fatigue (tiredness)

  • infusion-related reaction

  • musculoskeletal pain

  • nausea (feeling sick)

  • decreased appetite

  • urinary tract infection.

Serious side effects

The serious side effects listed in the prescribing information include1,3:

  • immune-mediated pneumonitis

  • immune-mediated hepatitis

  • immune-mediated colitis

  • immune-mediated endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycaemia)

  • immune-mediated nephritis and renal dysfunction

  • other immune-mediated adverse reactions

  • infusion-related reactions.

Use in a specific population

Bavencio (avelumab) can be fatal for a fetus, it is advised to avoid pregnancies and breast-feeding, use effective contraception during treatment with Bavencio (avelumab) and for at least 1 month after the last dose of Bavencio (avelumab)1,3.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,3.

More Information
Working ingredient avelumab
Shipping method Cold chain (temperature controlled)
Package 1 vial of 200 mg / 10 ml -
Therapeutic Area Oncology
Oncology Urothelial Carcinoma, Skin Cancer
Indication Metastatic Merkel cell carcinoma (MCC)
Indication Locally advanced or metastatic urothelial carcinoma
Administration Intravenous
Mode of Action PD-L1 blocking antibody (immunotherapy)
Strength 20
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Merck Serono Europe Limited
HS Code N/A
CAS Number N/A

Merkel Cell Carcinoma

Second-line treatment

The Food and Drug Administration (FDA) and European Medical Agency (EMA) approvals of Bavencio (avelumab) for metastatic Merkel cell carcinoma (MCC) were based on a single-arm (no comparator medicine) trial (JAVELIN Merkel 200 trial). This study involved a total of 88 patients with metastatic MCC whose disease had progressed on, or after chemotherapy was administered for distant metastatic disease1,3.

Results

Among the efficacy outcome measures were objective response rate (ORR) measured at 18 months follow-up3. Additional outcome measured was the duration of response (DOR) and progression-free survival (PFS)3.

Bavencio (avelumab) did not result in outstanding response rate, however, the responses lasted for at least 6 months. This is an important outcome for patients affected by Merkel cell carcinoma (MCC), since chemotherapy medicines usually produce effects of shorter duration4.

The ORR was1,3:

  • 33% [95% CI: 23.3, 43.8]

  • with 11.4% complete responses.

The DOR:

  • ranged from 2.8 months1,3 to over 24.9 months3

  • was above 6 months in 93% of patients3

  • was above 12 months in 71% of patients3.

The PFS:

  • was in median 2.7 months [95% CI: 1.4, 6.9]3

  • 6-months PFS rate was 40% [95% CI: 29, 50]3

  • 12-months PFS rate was 29% [95% CI: 19, 39]3.

First-line treatment

The European Medical Agency (EMA) approval also included results from a second part of the same study. This part of the study involved 39 patients who had not been treated yet for their metastatic disease.

Results

The main efficacy outcome measures were the objective response rate (ORR), the duration of response (DOR) and progression-free survival measured on 29 patients that had been monitored for at least 13 weeks after treatment completion1.

From the early results of this study emerged that the majority of patients who have not had previous chemotherapy also respond to treatment with Bavencio (avelumab)4.

The objective response rate was3:

  • 62.1% [95% CI: 42.3, 79.3]

  • with 13.8% complete responses.

The duration of response:

  • ranged from over 1.2 months3 to over 8.3 months3,

  • was above 3 months in 93 % of patients3.

The progression-free survival:

  • was in median 9.1 months [95% CI: 1.9, non estimable]3

  • 3-months PFS rate was 67% [95% CI: 48,80]3

  • 12-months PFS rate was 29% [95% CI: 19, 39]3.

Urothelial carcinoma

Second-line treatment

The Food and Drug Administration (FDA) approval of Bavencio (avelumab) for locally advanced or metastatic urothelial carcinoma (UC) was based on a single-arm trial (JAVELIN Solid Tumor trial), i.e. Bavencio (avelumab) was not tested against another medicine/placebo. This study involved a total of 242 patients with metastatic MCC whose disease had progressed on, or after platinum-containing chemotherapy1.

Results

The main efficacy outcome measures were the objective response rate (ORR) and the duration of response (DOR) measured on 226 and 161 patients that had been monitored for, respectively, at least 13 weeks and 6 months after treatment completion1.

Patients were treated for a median of 2.0 months before a response was evident. Although the response rate was not outstanding, for some patients had responded to the treatment for over a year1.

The ORR was1:

  • 13.3% [95% CI: 9.1, 18.4] (with 4% complete responses) in the 226 patients that were monitored for more than 13 weeks after treatment1

  • 16.1% [95% CI: 10.8, 22.8] (with 5.6% complete responses) in the 161 patients that were monitored for more than 6 months after treatment1.

The DOR:

  • ranged from over 1.4 months1 to over 17.4 months1 for both the 226 patients that were monitored for more than 13 weeks after treatment and the 161 patients that were monitored for more than 6 months after treatment1.

1. Summary of Product Characteristics [FDA]: Bavencio (avelumab) [PDF]
    FDA.gov, www.accessdata.fda.gov, October 2017.

2. Drugs.com. FDA Approves Bavencio
    23/03/2017, cited on 14/06/2017.

3. Summary of Product Characteristics [EMA]: Bavencio (avelumab) [PDF]
    Merck Serono Ltd., Oct. 2017.

4. EMA. Human Medicines: Bavencio (avelumab)
    (last update: 13/10/2017) cited October 2017.

5. Abcam.com. Cancer: Cancer immunotherapy and the PD-1/PD-L1 checkpoint pathway
    cited February 2018.

6. Public Summary [TGA]: Bavencio (avelumab) [PDF]
    Merck Serono Ltd., Jan. 2018.


Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
Dynamic Weight No
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.