Αρχική World News FDA Grants Accelerated Approval to Pembrolizumab for Locally Recurrent Unresectable or Metastatic...

FDA Grants Accelerated Approval to Pembrolizumab for Locally Recurrent Unresectable or Metastatic TNBC

On 13 November 2020, the US Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 (CPS ≥10) as determined by an FDA approved test.

FDA also approved the PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.) as a companion diagnostic for selecting patients with TNBC for pembrolizumab.

Approval was based on KEYNOTE-355 (NCT02819518), a multicentre, double-blind, randomised, placebo-controlled study in patients with locally recurrent unresectable or metastatic TNBC, who had not been previously treated with chemotherapy in the metastatic setting. Patients were randomised (2:1) to receive pembrolizumab 200 mg on day 1 every 3 weeks or placebo in combination with different chemotherapy treatments (paclitaxel protein-bound, or paclitaxel, or gemcitabine plus carboplatin) via intravenous infusion.

The main efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent review according to RECIST v1.1, tested in the subgroup of patients with CPS ≥10. Median PFS was 9.7 months (95% confidence interval [CI] 7.6, 11.3) in the pembrolizumab plus chemotherapy arm and 5.6 months (95% CI 5.3, 7.5) in the placebo arm (hazard ratio 0.65; 95% CI 0.49, 0.86; one-sided p-value = 0.0012).

The most common adverse reactions (incidence ≥20%) in patients receiving pembrolizumab plus chemotherapy in KEYNOTE-355 were fatigue, nausea, diarrhoea, constipation, vomiting, alopecia, rash, cough, decreased appetite, headache. The most common laboratory abnormalities (incidence ≥20%) in patients receiving pembrolizumab plus chemotherapy were anaemia, leukopaenia, neutropaenia, lymphopaenia, thrombocytopenia, elevated ALT and AST, hyperglycaemia, hypoalbuminaemia, increased alkaline phosphatase, hypocalcaemia, hyponatraemia, hypophosphataemia, and hypokalaemia.

The recommended pembrolizumab dose for adult patients with locally recurrent unresectable or metastatic TNBC is 200 mg every 3 weeks or 400 mg every 6 weeks administered prior to chemotherapy until disease progression, unacceptable toxicity, or up to 24 months. When given with pembrolizumab, either paclitaxel protein bound 100 mg/m2 on days 1, 8 and 15 every 28 days, or paclitaxel 90 mg/m2 on days 1, 8 and 15 every 28 days, or gemcitabine 1000 mg/m2 plus carboplatin AUC 2 mg/mL/min on Days 1 and 8 every 21 days is administered via intravenous infusion.

Full prescribing information for KEYTRUDA is available here.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted accelerated approval based on PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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 FDA’s Oncology Center of Excellence 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

Breast Cancer Survivor Invents Warming Bra Insert to Combat Cold Feeling of Breast Implants

In 2013, Kristen Carbone, of Providence, Rhode Island, had a preventative mastectomy to help protect herself against breast cancer after her mother died of...

FDA Approves Daratumumab plus Hyaluronidase-fihj, Carfilzomib, and Dexamethasone for Relapsed or Refractory Multiple Myeloma

On 30 November 2021, the US Food and Drug Administration (FDA) approved daratumumab plus hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) and carfilzomib (Kyprolis, Amgen,...

Thanks For Making This GivingTuesday Our Best One Yet!

We set ambitious goals for GivingTuesday, but they were driven by a time of great need. With your help, we hoped to provide food and...

Over 600 people in England set to benefit from innovative lung cancer treatment

<img width="620" height="348" src="https://34p2k13bwwzx12bgy13rwq8p-wpengine.netdna-ssl.com/wp-content/uploads/2021/05/lung_cell_cropped-hero.jpg" class="attachment-featuredImage size-featuredImage" alt="Lung cancer cell" loading="lazy" srcset="https://34p2k13bwwzx12bgy13rwq8p-wpengine.netdna-ssl.com/wp-content/uploads/2021/05/lung_cell_cropped-hero.jpg 620w, https://34p2k13bwwzx12bgy13rwq8p-wpengine.netdna-ssl.com/wp-content/uploads/2021/05/lung_cell_cropped-hero-300x168.jpg 300w, https://34p2k13bwwzx12bgy13rwq8p-wpengine.netdna-ssl.com/wp-content/uploads/2021/05/lung_cell_cropped-hero-220x123.jpg 220w, https://34p2k13bwwzx12bgy13rwq8p-wpengine.netdna-ssl.com/wp-content/uploads/2021/05/lung_cell_cropped-hero-150x84.jpg 150w" sizes="(max-width: 620px) 100vw, 620px" data-attachment-id="18781" data-permalink="https://news.cancerresearchuk.org/2020/09/11/targeted-drug-for-lung-cancer-approved-for-nhs-use-in-england/lung_cell_cropped-hero/"...

Touching a nerve: How neuroscience could advance our understanding of cancer

KTSDESIGN/SCIENCE PHOTO LIBRARY When supporters donate to our work, their combined generosity might lead to a new discovery that inches us closer to, for example,...

Nivolumab Demonstrates Clinical Benefits in a Statistically Evaluable Number of Patients with CUP

An investigator-initiated phase II study is the first to show that nivolumab has clinical activity with manageable toxicity in a statistically evaluable number of...