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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
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                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Home
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          Resources for Information | Approved Drugs
          FDA D.I.S.C.O. Burst Edition: FDA approvals of Tabrecta (capmatinib) for metastatic non-small cell lung cancer and Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-mutant non-small cell lung cancerResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approvals of Tabrecta (capmatinib) for metastatic non-small cell lung cancer and Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-mutant non-small cell lung cancer
  
  	
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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 another quick update on two recent FDA cancer drug approvals.

On August 10, 2022, the FDA granted regular approval to capmatinib (brand name Tabrecta) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test.

Capmatinib was previously granted accelerated approval for the same indication on May 6, 2020, based on initial overall response rate and duration of response in the GEOMETRY mono-1 trial, a multicenter, non-randomized, open-label, multi-cohort study. The conversion to regular approval was based on data from an additional 63 patients, as well as an additional 22 months of follow- up time to assess durability of response and verify clinical benefit.

Efficacy was demonstrated in 160 patients with metastatic non-small cell lung cancer with a mutation leading to mesenchymal-epithelial transition exon 14 skipping. Patients received capmatinib 400 mg orally twice daily until disease progression or unacceptable toxicity.

The primary efficacy measures were objective response rate and duration of response as determined by a Blinded Independent Review Committee. Among 60 treatment-naïve patients, objective response rate was 68% with a duration of response of 16.6 months. Among 100 previously treated patients, objective response rate was 44% with a duration of response of 9.7 months.

The median age of patients was 71 years. Selected demographics were reported as follows: 61% female, 77% White, 61% never smoked, 83% had adenocarcinoma, and 16% had CNS metastases. Among previously treated patients, 81% received one, 16% received two, and 3% received three prior lines of systemic therapy. Amongst previously treated patients, 86% received prior platinum-based chemotherapy.

The most common adverse reactions occurring in more than 20% in patients were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.

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 may be ongoing at the other regulatory agencies.

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

On August 11, 2022, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have activating human epidermal growth factor receptor 2 HER2 mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-mutant non-small cell lung cancer.

FDA also approved the Life Technologies Corporation’s OncomineTM Dx Target Test and the Guardant Health, Inc.’s Guardant360® CDx as companion diagnostics for Enhertu. If no mutation is detected in a plasma specimen, the tumor tissue should be tested.

Enhertu was evaluated at a 6.4 mg/kg dose across multiple trials and at a 5.4 mg/kg dose in a randomized dose-finding trial. Response rates were consistent across dose levels. Increased rates of interstitial lung disease/pneumonitis were observed at the higher dose. The efficacy results of the approved recommended dose of 5.4 mg/kg given intravenously every 3 weeks are described below.

Efficacy for accelerated approval was based on DESTINY-Lung02, a multicenter, multi-cohort, randomized, blinded, dose-optimization trial. Eligible patients were required to have unresectable or metastatic HER2-mutant non-squamous non-small cell lung cancer with disease progression after prior systemic therapy. Patients were selected for treatment with Enhertu based on the presence of activating HER2 mutations in a tumor specimen. Patients received Enhertu 5.4 mg/kg by intravenous infusion, every 3 weeks until unacceptable toxicity or disease progression.

Of the 52 patients in the primary efficacy population DESTINY-Lung02, the median age was 58 years, 69% were female; 79% were Asian, 12% were White, and 10% were of other races. The major efficacy outcome measures were confirmed objective response rate as assessed by blinded independent central review using RECIST v1.1 and duration of response. The confirmed objective response rate was 58% and the median duration of response was 8.7 months.

The prescribing information includes a Boxed Warning advising health professionals of the risk of interstitial lung disease and embryo-fetal toxicity.

This application used advice from the FDA Oncology Center of Excellence Project Optimus to conduct a dose randomization study, which led to a lower dose being approved. For more information regarding the OCE’s efforts to modernize dose selection for oncology products, refer to Project Optimus.

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 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 to FDAOncology@fda.hhs.gov. Thanks for tuning into the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      09/16/2022Resources 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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