Showing posts from July, 2021

US FDA approves Merck’s Keytruda in combo with chemotherapy to treat high-risk early-stage TNBC

Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the phase 3 KEYNOTE-522 trial. TNBC is an aggressive type of breast cancer with an increased risk for disease recurrence. KEYNOTE-522 showed that Keytruda in combination with chemotherapy (carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide) before surgery and continued as a single agent after surgery significantly prolonged event-free survival (EFS) versus the same neoadjuvant chemotherapy regimens alone in patients with previously untreated stage II or stage III TNBC – there was a 37% reduction in the risk of disease progression that precluded definitive su

Merck announces positive event-free survival data from phase 3 KEYNOTE-522 study of Keytruda to treat triple-negative breast cancer

Merck announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant phase 3 study KEYNOTE-522. The trial investigated neoadjuvant Keytruda, Merck’s anti-PD-1 therapy, plus chemotherapy followed by adjuvant Keytruda as monotherapy (the Keytruda regimen) compared with neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy-placebo regimen) in patients with high-risk early-stage triple-negative breast cancer (TNBC). This is the first time an anti-PD-1/L1 therapy has demonstrated a statistically significant EFS result as combined neoadjuvant and adjuvant therapy for these patients. These results are being presented today during a European Society for Medical Oncology (ESMO) Virtual Plenary. After a median follow-up of 39 months, the Keytruda regimen reduced the risk of EFS events by 37% (HR=0.63 [95% CI, 0.48-0.82]; p=0.00031) versus the chemotherapy-placebo regimen – a statistically significant and clinically meaningful EFS result. EFS was defined

Spice up For Most cancers Care In India: Tata Memorial Health center, IIT Bombay Conducts First CAR-T Mobile Treatment In Early Section Medical Trial

Chimeric antigen receptor T-cell (CAR-T) treatment has emerged as a leap forward in most cancers remedy. Medical research performed international have proven promising ends up in end-stage sufferers, particularly the ones affected by acute lymphoblastic leukemia. Whilst this generation has exceptional healing possible for most cancers sufferers, it’s not recently to be had in India. Every affected person’s CAR-T mobile treatment prices Rs 3-4 crore. The problem is due to this fact to expand this generation in an economical means and make it to be had to sufferers. The complexity of producing is a significant motive force of treatment prices. To advertise and fortify the advance of CAR-T mobile generation in opposition to most cancers and different sicknesses, BIRAC and DBT have initiated projects and introduced specialised calls to ask proposals during the last 2 years. June 4, 2021 was once a ancient day for TMH, IIT Bombay group and most cancers care in India as the primary CAR-T mob

Merck plans to withdraw US accelerated approval of Keytruda to treat recurrent locally advanced or metastatic gastric

  Merck announced that the company plans to voluntarily withdraw the US accelerated approval indication for Keytruda for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS =1)] as determined by a US Food and Drug Administration (FDA)-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal growth factor receptor 2 (HER2)/neu-targeted therapy. The decision was made in consultation with the FDA following the April 29 Oncologic Drugs Advisory Committee evaluation of this third-line gastric cancer indication for Keytruda as a monotherapy because it failed to meet its post-marketing requirement of demonstrating an overall survival benefit in a phase 3 study. As agreed with the FDA, Merck will initiate the withdrawal in six month