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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: Approval of Padcev (enfortumab vedotin-ejfv) for locally advanced or metastatic urothelial cancer and Darzalex Faspro (daratumumab and hyaluronidase-fihj) with pomalidomide and dexamethasone for multiple myelomaResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: Approval of Padcev (enfortumab vedotin-ejfv) for locally advanced or metastatic urothelial cancer and Darzalex Faspro (daratumumab and hyaluronidase-fihj) with pomalidomide and dexamethasone for 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 July 9, 2021, FDA approved enfortumab vedotin-ejfv (brand name Padcev), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who

have previously received a programmed death receptor-1 or programmed death-ligand inhibitor and platinum-containing chemotherapy, or
	are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapyFDA granted accelerated approval in December 2019 to enfortumab vedotin-ejfv for patients with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 or programmed death-ligand inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Trial EV-301 was an open-label, randomized, multicenter trial required to confirm the clinical benefit of the 2019 accelerated approval. This trial enrolled 608 patients with locally advanced or metastatic urothelial cancer who received a prior programmed death receptor-1 or programmed death-ligand inhibitor and platinum-based chemotherapy. Patients were randomized 1:1 to receive either enfortumab vedotin-ejfv or investigator’s choice of single-agent chemotherapy (docetaxel, paclitaxel, or vinflunine).

The primary efficacy endpoint was overall survival with key secondary efficacy endpoints of progression-free survival, and overall response rate assessed by investigator using RECIST 1.1. Median overall survival was 12.9 months for patients with the enfortumab vedotin-ejfv arm versus 9.0 months for those receiving chemotherapy. Median progression-free survival was 5.6 months compared to 3.7 months, respectively. The overall response rate was 40.6% versus 17.9%, respectively.

Efficacy for patients ineligible for cisplatin-containing chemotherapy was evaluated in Cohort 2 of EV-201, a single-arm, multi-cohort, international trial in 89 patients with locally advanced or metastatic urothelial cancer who received a prior programmed death receptor-1 or programmed death-ligand inhibitor and were ineligible for cisplatin-containing chemotherapy. The primary efficacy endpoint was confirmed overall response rate, assessed by blinded independent central review, and the key secondary efficacy endpoint was response duration. The confirmed overall response rate was 51%, including 22% with complete responses, and the median response duration was 13.8 months.

A boxed warning for serious skin reactions, including Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, and a warning for pneumonitis were added to the Prescribing Information.

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.

This review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application approximately 5 weeks ahead of the FDA goal date.

On July 9, 2021, FDA also approved daratumumab and hyaluronidase-fihj (brand name Darzalex Faspro) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

Efficacy was evaluated in APOLLO, an open-label, active-controlled trial with 304 patients randomized 1:1 to Darzalex Faspro with pomalidomide and dexamethasone vs pomalidomide and dexamethasone alone.

The main efficacy outcome measure was progression-free survival. The median progression-free survival was 12.4 months in the Darzalex Faspro with pomalidomide and dexamethasone treatment group and 6.9 months in the pomalidomide and dexamethasone treatment group, representing a 37% reduction in the risk of disease progression or death for patients treated with Darzalex Faspro with pomalidomide and dexamethasone versus with pomalidomide and dexamethasone.

The most common adverse reactions with an incidence of greater than 20% in patients with multiple myeloma who received Darzalex Faspro with pomalidomide and dexamethasone were fatigue, pneumonia, upper respiratory tract infection, and diarrhea.

Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatFDA.

Healthcare 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 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:
      07/22/2021Resources 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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