Kan dette være årsaken :

Denne nyheten kom i 2023

https://classic.clinicaltrials.gov/ct2/show/NCT03184571

Idag dukket kl 16:14 det opp en nyhet som kan være meget relevant for BerGenBio aksjonærer :


FDA Approves Pembrolizumab with Chemotherapy for Primary Advanced or Recurrent Endometrial Carcinoma

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Tuesday, June 18, 2024

Oncology News Burst from the FDA:
FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma

In cooperation with the Food and Drug Administration (FDA), and as a service to our members, SITC will periodically distribute information about newly approved therapies for cancer patients. This helps the FDA inform oncologists and professionals in oncology-related fields of recent approvals in a timely manner. Included in the email from the FDA will be a link to the product label, which will provide the relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, SITC does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.
On June 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.

Full prescribing information for Keytruda will be posted on Drugs@FDA.

Efficacy was evaluated in KEYNOTE-868/NRG-GY018 (NCT03914612), a multicenter, randomized, double-blind, placebo-controlled trial enrolling 810 patients with advanced or recurrent endometrial carcinoma. The trial included two separate cohorts based on mismatch repair (MMR) status: 222 patients in the mismatch repair deficient (dMMR) cohort, and 588 patients in the mismatch repair (pMMR) proficient cohort. Patients were randomized (1:1) to one of the following treatment arms:

Pembrolizumab 200 mg every 3 weeks, paclitaxel 175 mg/m2 and carboplatin AUC 5 mg/mL/min for 6 cycles, followed by pembrolizumab 400 mg every 6 weeks for up to 14 cycles.
Placebo every 3 weeks, paclitaxel 175 mg/m2 and carboplatin AUC 5 mg/mL/min for 6 cycles, followed by placebo every 6 weeks for up to 14 cycles.
Randomization was stratified according to MMR status, ECOG performance status (0 or 1 vs. 2), and prior adjuvant chemotherapy.

The major efficacy outcome measure was progression-free survival (PFS), assessed by the investigator according to RECIST 1.1. In the dMMR cohort, median PFS was not reached (NR) (95% CI: 30.7, NR) in the pembrolizumab and chemotherapy arm and 6.5 months (95% CI: 6.4, 8.7) in the placebo and chemotherapy arm (Hazard ratio [HR] 0.30 [95% CI: 0.19, 0.48]; p-value <0.0001). In the pMMR cohort, median PFS was 11.1 months (95% CI: 8.7, 13.5) in the pembrolizumab and chemotherapy arm and 8.5 months (95% CI: 7.2, 8.8) for those receiving placebo and chemotherapy arm (HR 0.60 [95% CI: 0.46, 0.78; p-value <0.0001).

Adverse reactions associated with pembrolizumab and chemotherapy were generally similar to those previously reported for pembrolizumab or chemotherapy with the exception of a higher incidence of rash. See the prescribing information for complete adverse reactions.

The recommended pembrolizumab dose is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months.

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. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada (HC), and Israel’s Ministry of Health (IMoH). The application reviews are ongoing at the other regulatory agencies.

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

This application was granted priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

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 or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X @FDAOncology.