FDA Grants Regular Approval to Padcev for Pretreated Metastatic or Advanced Bladder Cancer


Approximately 18 months after granting Padcev an accelerated approval, the Food and Drug Administration granted a regular approval to the treatment for certain previously treated patients with locally advanced or metastatic urothelial carcinoma.

The Food and Drug Administration (FDA) granted Padcev (enfortumab vedotin-ejfv) a regular approval for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy; or who are ineligible for cisplatin-containing chemotherapy and have undergone one or more prior lines of therapy.

Padcev, a Nectin-4—directed antibody and microtubule inhibitor conjugate, was originally granted an accelerated approval in December 2019. Then, findings from the EV-301 and EV-201 trials confirmed the benefit.

The EV-301 trial included 608 patients with locally advanced or metastatic disease who had prior PD-1 or PD-L1 inhibitor treatment, as well as platinum-based chemotherapy. Half the patients in the trial were given 1.25 mg/kg of Padcev on days 1, 8 and 15 of a 28-day cycle, while the other half of patients received investigator’s choice of a single-agent chemotherapy (docetaxel, paclitaxel or vinflunine).

The average overall survival (OS) was 12.9 months, for patients given Padcev, compared to nine months for those given chemotherapy. Average progression-free survival (PFS) defined as the time patients survived without their disease getting worse, was 5.6 months in the Padcev patient group and 3.7 months in the chemotherapy patient group. Overall, 40.6% of patients responded to Padcev, compared to only 17.9% for chemotherapy.

EV-201 contained a group of 89 patients who had locally advanced or metastatic urothelial cancer who received prior PD-1 or PD-L1 treatment and were not eligible to get cisplatin-containing chemotherapy. In this trial, 51% of patients’ disease shrunk because of Padcev treatment, and this included 22% of patients with complete responses, where there was no detectable trace of cancer. On average, patients’ response lasted 13.8 months.

Common side effects seen with Padcev were: rash, aspartate aminotransferase (an enzyme released when cells are damaged) increased, glucose increased, creatinine increased, fatigue, peripheral neuropathy, lymphocytes decreased, alopecia, decreased appetite, hemoglobin decreased, diarrhea, sodium decreased, nausea, itch, phosphate decreased, altered sense of taste, alanine aminotransferase increased, anemia, albumin decreased, neutrophils decreased, urate increased, lipase increased, platelets decreased, weight decreased and dry skin.

The drug has a boxed warning for serious skin reactions, which can include Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, as well as a warning for pneumonitis. So, if patients experience any skin changes or difficulties breathing, they should contact their care team immediately.

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