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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 Retevmo (selpercatinib) for adult patients with locally advanced or metastatic RET fusion-positive solid tumors, and Retevmo (selpercatinib) for adult patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancerResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approvals of Retevmo (selpercatinib) for adult patients with locally advanced or metastatic RET fusion-positive solid tumors, and Retevmo (selpercatinib) for adult patients with locally advanced or metastatic RET fusion-positive 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 September 21, 2022, the FDA granted accelerated approval to selpercatinib (brand name Retevmo) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Efficacy was demonstrated in LIBRETTO-001, a multicenter, open-label, multi-cohort trial that evaluated 41 patients with rearranged during transfection fusion-positive tumors with disease progression on or following prior systemic treatment or who had no satisfactory alternative treatment options. The efficacy evaluation was supported by data in 343 patients with rearranged during transfection fusion-positive non-small cell lung cancer and thyroid cancer enrolled in the same trial already described in product labeling. Patients received selpercatinib until disease progression or unacceptable toxicity.

The primary efficacy measures were overall response rate and duration of response as determined by a Blinded Independent Review Committee. Among 41 evaluable patients, overall response rate was 44% with a duration of response of 24.5 months. Tumor types with responses included pancreatic adenocarcinoma, colorectal, salivary, unknown primary, breast, soft tissue sarcoma, bronchial carcinoid, ovarian, small intestine, and cholangiocarcinoma.

The median age of patients was 50 years, ranging from 21 to 85. Selected demographics were as follows: 54% female; 68% White, 24% Asian, 4.9% Black; 7% Hispanic/Latino; 95% had ECOG performance status of 0 or 1; 95% had metastatic disease. Thirty-seven patients received prior systemic therapy. The most common cancers were pancreatic, colorectal, salivary, and unknown primary. Rearranged during transfection fusion-positive status was detected in 97.6% of patients using next-generation sequencing and 2.4% using fluorescence in situ hybridization.

The most common adverse reactions occurring in more than 25% of patients were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 2 months ahead of the FDA goal date.

On September 21, 2022, the FDA also granted regular approval to selpercatinib (brand name Retevmo) for adult patients with locally advanced or metastatic non-small cell lung cancer with a rearranged during transfection gene fusion, as detected by an FDA-approved test.

FDA also approved the Oncomine Dx Target Test as a companion diagnostic for selpercatinib.

Selpercatinib was previously granted accelerated approval for the non-small cell lung cancer indication on May 8, 2020, based on initial overall response rate and duration of response in 144 patients enrolled in the LIBRETTO-001 trial, a multicenter, open-label, multi-cohort trial. The conversion to regular approval was based on data from an additional 172 patients and 18 months of additional follow-up to assess durability of response.

Efficacy was demonstrated in 316 patients with locally advanced or metastatic rearranged during transfection fusion-positive non-small cell lung cancer. Patients received selpercatinib until disease progression or unacceptable toxicity.

The primary efficacy measures were overall response rate and duration of response as determined by a Blinded Independent Review Committee. Among 69 treatment-naïve patients, overall response rate was 84% with a duration of response of 20.2 months. Among 247 patients previously treated with platinum-based chemotherapy, overall response rate was 61% with a duration of response of 28.6 months.

The median age of patients was 61 years, ranging from 23 to 92. Selected demographics were as follows: 58% female; 49% White, 41% Asian and 5% Black; 97% had ECOG performance status 0 or 1; 97% had metastatic disease. Previously treated patients received a median of two prior systemic therapies; 58% had received prior anti PD 1/PD-L1 therapy.

The most common adverse reactions occurring in more than 25% of patients were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.

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:
      11/07/2022Resources 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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