Αρχική World News FDA Grants Regular Approval to Enfortumab Vedotin-ejfv for Locally Advanced or Metastatic...

FDA Grants Regular Approval to Enfortumab Vedotin-ejfv for Locally Advanced or Metastatic Urothelial Cancer

On 9 July 2021, the US Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who

  • have previously received a PD1 or PD-L1 inhibitor and platinum-containing chemotherapy, or
  • are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

FDA granted accelerated approval in December 2019 to enfortumab vedotin-ejfv for patients with locally advanced or metastatic urothelial cancer who have received a PD1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

The EV-301 (NCT03474107) was an open-label, randomised, multicentre study required to confirm the clinical benefit of the 2019 accelerated approval. This study enrolled 608 patients with locally advanced or metastatic urothelial cancer who received a prior PD1 or PD-L1 inhibitor and platinum-based chemotherapy. Patients were randomised (1:1) to receive either enfortumab vedotin-ejfv 1.25 mg/kg on days 1, 8 and 15 of a 28-day cycle or investigator’s choice of single-agent chemotherapy (docetaxel, paclitaxel, or vinflunine).

The primary efficacy endpoint was overall survival (OS) with key secondary efficacy endpoints of progression-free survival (PFS), and overall response rate (ORR) assessed by investigator using RECIST v1.1.

Median OS was 12.9 months (95% confidence interval [CI] 10.6, 15.2) for patients on the enfortumab vedotin-ejfv arm (n=301) versus 9.0 months for those receiving chemotherapy (n=307) (95% CI 8.1, 10.7) (HR 0.70; 95% CI 0.56, 0.89; p = 0.0014).  Median PFS was 5.6 months (95% CI 5.3, 5.8) compared with 3.7 months (95% CI 3.5, 3.9), respectively (HR 0.62; 95% CI 0.51, 0.75; p < 0.0001. The ORR was 40.6% (95% CI 34.9, 46.5) versus 17.9% (95% CI 13.7, 22.8), respectively (p < 0.0001).

Efficacy for patients ineligible for cisplatin-containing chemotherapy was evaluated in Cohort 2 of EV-201 (NCT03219333), a single-arm, multi-cohort, international study in 89 patients with locally advanced or metastatic urothelial cancer who received a prior PD1 or PD-L1 inhibitor and were ineligible for cisplatin-containing chemotherapy. The primary efficacy endpoint was confirmed ORR, assessed by blinded independent central review, and the key secondary efficacy endpoint was response duration. The confirmed ORR was 51% (95% CI 39.8, 61.3), including 22% with complete responses, and the median response duration was 13.8 months (95% CI 6.4, not estimable).

The most common adverse reactions, including laboratory abnormalities (≥20%) were rash, aspartate aminotransferase increased, glucose increased, creatinine increased, fatigue, peripheral neuropathy, lymphocytes decreased, alopecia, decreased appetite, haemoglobin decreased, diarrhoea, sodium decreased, nausea, pruritus, phosphate decreased, dysgeusia, alanine aminotransferase increased, anaemia, albumin decreased, neutrophils decreased, urate increased, lipase increased, platelets decreased, weight decreased and dry skin.

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

The recommended dose of enfortumab vedotin-ejfv is 1.25 mg/kg (up to a maximum dose of 125 mg) administered as an intravenous infusion over 30 minutes on days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

Full prescribing information for Padcev is available here.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Health Canada and Australia’s Therapeutic Goods Administration.

This review used the Real-Time Oncology Review pilot programme, 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.

This application was granted priority review and breakthrough therapy designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate.

Source

NEWSLETTER

Συμπληρώστε το email σας για να λαμβάνετε τις σημαντικότερες ειδήσεις από το ogkologos.com

Βρείτε μας

2,449ΥποστηρικτέςΚάντε Like
57ΑκόλουθοιΑκολουθήστε

Διαβαστε Επίσης

Καρκίνος και Κορωνοϊός (COVID-19) ΜΕΡΟΣ Α

Εάν είστε καρκινοπαθής, το ανοσοποιητικό σας σύστημα μπορεί να μην είναι τόσο ισχυρό όσο κανονικά, έτσι μπορεί να ανησυχείτε για τους κινδύνους που σχετίζονται...

ΠΑΓΚΟΣΜΙΑ ΗΜΕΡΑ ΚΑΡΚΙΝΟΥ

Η Παγκόσμια Ημέρα Κατά του Καρκίνου καθιερώθηκε με πρωτοβουλία της Διεθνούς Ένωσης κατά του Καρκίνου (UICC), που εκπροσωπεί 800 οργανώσεις σε 155 χώρες του...

ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ)

ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ) Γράφει ο Δρ Παπαδούρης Σάββας, Παθόλογος-Ογκολόγος   Ο ΜΜΚΠ βρίσκεται αναλογικά στο 80% και πλέον του συνολικού...

Διατρέχουν όντως οι καρκινοπαθείς μεγαλύτερο κίνδυνο λόγω κοροναϊού;

Σε πρακτικό επίπεδο, τα δεδομένα των σχετικών μελετών υποδηλώνουν ότι η χημειοθεραπεία ή οι άλλες αντι-νεοπλασματικές θεραπείες δεν αυξάνουν σημαντικά τον κίνδυνο θνησιμότητας από...

FDA: Η ακτινοβολία των smartphones δεν προκαλεί καρκίνο

Σε μια νέα έκθεσή της, η Υπηρεσία Τροφίμων και Φαρμάκων (FDA) των ΗΠΑ αναφέρει ότι επανεξέτασε τις σχετικές επιστημονικές έρευνες που δημοσιεύθηκαν τα τελευταία...

Νέα ανακάλυψη, νέα ελπίδα για τον καρκίνο

Ένα νεοανακαλυφθέν τμήμα του ανοσοποιητικού μας συστήματος θα μπορούσε να αξιοποιηθεί για την αντιμετώπιση όλων των ειδών καρκίνου, σύμφωνα με επιστήμονες του πανεπιστημίου Cardiff...
- Advertisment -

Ροή Ειδήσεων

Despite Proven Safety of HPV Vaccines, More Parents Have Concerns

October 22, 2021, by NCI Staff Credit: National Cancer Institute Despite more than 15 years of consistent evidence that HPV vaccines are safe and effective, a...

FDA Approves Atezolizumab as Adjuvant Treatment for Non-Small Cell Lung Cancer

On 15 October 2021, the US Food and Drug Administration (FDA) approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment following resection and platinum-based chemotherapy...

Breast Cancer Survivor Uses Comedy to Spread Awareness and Address Disparities

Suzette Simon lost her mother to breast cancer. In 2020, she learned that she had the disease, as well. Realizing how much harder breast...

Why Wearing Comfortable Clothes During Cancer Treatment Matters

Voices on Cancer is an award-winning Cancer.Net Blog series where advocates share their stories and the lessons they have learned about being a cancer advocate. Cindy Trice is...

Breast cancer surgery: ‘I’m proud of the tattoos inked across my chest’

Wendy had a double mastectomy in 2017 and remained flat. “When the consultant told me, I remember crying and saying that I have 2 young...

EMA Recommends Granting a Marketing Authorisation for Zanubrutinib for the Treatment of Waldenström’s Macroglobulinaemia

On 16 September 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of...