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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
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                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Home
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          FDA D.I.S.C.O. Burst Edition: FDA approval of Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound)) for locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumorResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound)) for locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor
  
  	
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Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.

On November 22, 2021, the FDA approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (brand name Fyarro) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor.

Efficacy was evaluated in AMPECT, a multicenter, single-arm clinical trial in 31 patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor. Patients received sirolimus protein-bound particles at 100 mg/m2 on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate and duration of response , as assessed by blinded independent central review, using RECIST v.1.1. Overall response rate was 39%, including 2 patients with complete responses. Median duration of response was not reached. Among responders, 67% had a response lasting greater than 12 months and 58% had a response lasting greater than 24 months.

The most common adverse reactions reported in more than 30% of patients were stomatitis, fatigue, rash, infection, nausea, edema, diarrhea, musculoskeletal pain, decreased weight, decreased appetite, cough, vomiting, and dysgeusia. The most common grade 3 to 4 laboratory abnormalities reported in more than 6% of patients were decreased lymphocytes, increased glucose, decreased potassium, decreased phosphate, decreased hemoglobin, and increased lipase.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatFDA.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.

Follow the Division of Drug Information on Twitter @FDA_Drug_Info and the Oncology Center of Excellence @FDAOncology. Send your feedback via email to FDAOncology@fda.hhs.gov. Thanks for tuning into the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      12/06/2021Resources for Information | Approved Drugs

          
                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description
 
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