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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 Imjudo (tremelimumab) in combination with durvalumab for unresectable hepatocellular carcinoma, and Tecvayli (teclistamab-cqyv) for relapsed or refractory multiple myelomaResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approvals of Imjudo (tremelimumab) in combination with durvalumab for unresectable hepatocellular carcinoma, and Tecvayli (teclistamab-cqyv) for relapsed or refractory multiple myeloma
  
  	
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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 October 21, 2022, the FDA approved tremelimumab (brand name Imjudo) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma.

Efficacy was evaluated in HIMALAYA, a randomized 1:1:1, open-label, multicenter study in patients with confirmed unresectable hepatocellular carcinoma who had not received prior systemic treatment for hepatocellular carcinoma. This approval is based on a comparison of the 782 patients randomized to tremelimumab plus durvalumab to sorafenib.

The major efficacy outcome was overall survival. Tremelimumab plus durvalumab demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to sorafenib; median overall survival was 16.4 months versus 13.8 months. Additional efficacy outcomes included investigator-assessed progression-free survival and overall response rate according to RECIST v1.1. Median progression-free survival was 3.8 months and 4.1 months for the tremelimumab plus durvalumab and sorafenib arms, respectively. Overall response rate was 20.1% in the tremelimumab plus durvalumab arm and 5.1% for those treated with sorafenib.

The most common adverse reactions occurring in more than 20% of patients were rash, diarrhea, fatigue, pruritis, musculoskeletal pain and abdominal pain.

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

On October 25, 2022, the FDA granted accelerated approval to teclistamab-cqyv (brand name Tecvayli), the first bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Teclistamab-cqyv was evaluated in MajesTEC-1, a single-arm, multi-cohort, open-label, multi-center study. The efficacy population consisted of 110 patients who had previously received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and had not received prior BCMA-targeted therapy.

The main efficacy outcome measure was overall response rate as determined by the Independent Review Committee assessment using International Myeloma Working Group 2016 criteria. Overall response rate was 61.8%. With a median follow-up of 7.4 months among responders, the estimated duration of response rate was 90.6% at 6 months and 66.5% at 9 months.

The prescribing information for teclistamab-cqyv has a Boxed Warning for life threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome. Among patients who received teclistamab-cqyv at the recommended dose, cytokine release syndrome occurred in 72% of patients, neurologic toxicity in 57%, and immune effector cell-associated neurotoxicity syndrome in 6%. Grade 3 cytokine release syndrome occurred in 0.6% of patients and Grade 3 or 4 neurologic toxicity occurred in 2.4%.

Because of the risks of cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, teclistamab-cqyv is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (or REMS), called the Tecvayli REMS.

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.

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

                                                                                  Content current as of:
      11/23/2022Resources 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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