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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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          Resources for Information | Approved Drugs
          FDA D.I.S.C.O. Burst Edition: FDA approvals of Lumakras (sotorasib) for patients with KRAS G12C  mutated locally advanced or metastatic non-small cell lung cancer, and Truseltiq (infigratinib) for unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangementResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approvals of Lumakras (sotorasib) for patients with KRAS G12C  mutated locally advanced or metastatic non-small cell lung cancer, and Truseltiq (infigratinib) for unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement
  
  	
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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 two recent FDA cancer drug approvals.

On May 28, 2021, FDA granted accelerated approval to sotorasib (brand name Lumakras), a RAS GTPase family inhibitor, for adult patients with *KRAS G12C* mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA approved test, who have received at least one prior systemic therapy.

FDA also approved QIAGEN *therascreen*® K-RAS RGQ PCR kit for use in tissue, and the Guardant360® CDx for use in plasma, as companion diagnostics for Lumakras. If no mutation is detected in a plasma specimen, the tumor tissue should be tested.

Approval was based on CodeBreaK 100, a multicenter, single-arm, open label clinical trial which included patients with locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutations. Efficacy was evaluated in 124 patients whose disease had progressed on or after at least one prior systemic therapy.

The main efficacy outcome measures were objective response rate according to RECIST 1.1, as evaluated by blinded independent central review, and response duration. The objective response rate was 36% with a median response duration of 10 months.

The most common adverse reactions reported in more than 20% of patients were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. The most common laboratory abnormalities reported in more than 25% of patients were decreased lymphocytes, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium.

As part of the evaluation for this accelerated approval, FDA is requiring a postmarketing trial to investigate whether a lower dose will have a similar clinical effect.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The application reviews are ongoing at the other regulatory agencies.

This review used the Real-Time Oncology Review pilot program, which streamlined data-submission prior to the filing of the entire clinical application, the Assessment Aid, and the Product Quality Assessment Aid, voluntary submissions from the applicant to facilitate the FDA’s assessment. The FDA approved this application approximately 10 weeks ahead of the FDA goal date.

On May 28, 2021, FDA also granted accelerated approval to infigratinib (brand name Truseltiq), a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test.

The FDA also approved FoundationOne® CDx for selection of patients with fibro-blast growth factor receptor 2 fusion or other rearrangement, as a companion diagnostic device for treatment with infigratinib.

Efficacy was demonstrated in CBGJ398X2204, a multicenter open-label single-arm trial, that enrolled 108 patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibro-blast growth factor receptor 2 fusion or rearrangement as determined by local or central testing.

The major efficacy outcome measures were overall response rate and duration of response, as determined by blinded independent central review, according to RECIST 1.1. The overall response rate was 23%, with one complete response and 24 partial responses. The median duration of response was 5 months. Among the 23 responders, 8 patients maintained the response for 6 months or more.

The most common adverse reactions reported in more than 20% of patients were hyperphosphatemia, increased creatinine, nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, vision blurred and vomiting. The serious risks included hyperphosphatemia and retinal pigment epithelial detachment, and monitoring for these adverse reactions during treatment is recommended.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The application reviews are ongoing at the other regulatory agencies.

This review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, as well as the Assessment Aid and the Product Quality Assessment Aid, voluntary submissions 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 System 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 and thanks for tuning in to the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      06/17/2021Resources 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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