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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
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          FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib)Resources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib)
  
  	
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Welcome back to the DISCO, 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 January 15, 2021, FDA approved fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.

Efficacy was evaluated in a multicenter, open-label, randomized trial in patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal adenocarcinoma who had progressed on at least two prior regimens, including trastuzumab, a fluoropyrimidine- and a platinum-containing chemotherapy. The main efficacy outcome measures were overall survival and objective response rate assessed by independent central review in the intent-to-treat population. Additional efficacy outcome measures were progression-free survival and duration of response.

Overall survival was 12.5 months in the Enhertu arm compared with 8.4 months in the irinotecan or paclitaxel arm. Confirmed objective response rate was 40.5% in the Enhertu arm compared with 11.3% for those receiving irinotecan or paclitaxel. Median progression-free survival was 5.6 months in the Enhertu arm compared to 3.5 months in the irinotecan or paclitaxel arm. Median duration of response was 11.3 months vs 3.9 months, respectively.

The Prescribing Information includes a Boxed Warning to advise health care professionals of the risks of interstitial lung disease and embryo-fetal toxicity.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application approximately 6 weeks ahead of the goal date.

On January 22, 2021, the FDA approved the combination of nivolumab (brand name Opdivo) and cabozantinib (brand name Cabometyx) as first-line treatment for patients with advanced renal cell carcinoma.

Efficacy was evaluated in a randomized, open-label trial in patients with previously untreated advanced renal cell carcinoma. Patients were randomized to receive either nivolumab every 2 weeks in combination with cabozantinib once daily or sunitinib daily for the first 4 weeks of a 6-week cycle or 4 weeks on treatment followed by 2 weeks off.

The trial demonstrated a statistically significant improvement in progression-free survival, overall survival and confirmed overall response rate for patients treated with nivolumab plus cabozantinib compared with those who received sunitinib. Median progression-free survival per blinded independent central review was 16.6 months versus 8.3 months. Median overall survival was not reached in either arm. Confirmed overall response rate per blinded independent central review was 55.7% and 27.1% in the nivolumab plus cabozantinib and sunitinib arms, respectively.

The most common adverse reactions in more than 20% of patients receiving the combination of nivolumab and cabozantinib were diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysaesthesia syndrome, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

The nivolumab review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application. Both the nivolumab and the cabozantinib applications used the Assessment Aid. The FDA approved this application approximately one month ahead of the FDA goal date.

The 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. Thanks for tuning into the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      02/25/2021
              
              
Regulated Product(s)
		 DrugsResources 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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