Showing posts from November, 2020

NICE backs Braftovi for BRAF-positive colorectal cancer

The National Institute for Health and Care Excellence (NICE) has back Pierre Fabre’s Braftovi plus cetuximab for the treatment of BRAF-positive metastatic colorectal cancer. In September, NICE initially turned down Braftovi (encorafenib) after finding that the cost-effectiveness estimates were higher than what is normally considered value for money for the NHS. However, NICE has now decided to recommend the drug in combination with cetuximab for BRAF V600E mutation-positive metastatic colorectal cancer (mCRC) in adults who have had previous systemic treatment. The NICE decision is based on results from the phase III BEACON CRC trial, which showed that Braftovi plus cetuximab significantly improved median overall survival in patients with BRAF V600E-mutated mCRC and reduced the risk of death by 39%. The combination treatment also produced an improved objective response rate compared to the control arm. “We are delighted that NICE has recognised the value of Braftovi plus cetuximab for t

Roche Pharma Unveils Pan Tumor Liquid Biopsy Test In India

Mumbai: Roche Products (India) Pvt. Ltd. (Roche Pharma India) has recently announced the launch of FoundationOneLiquid CDx, Foundation Medicine's comprehensive pan-tumor liquid biopsy test for patients with solid tumors in India. US FDA approved the FoundationOneLiquid CDx, a comprehensive genomic profiling (CGP) test on August 26. This is the first test that can analyze more than 300 genes and multiple genomic signatures to optimize patient care. Cancer is a disease of the genome. Most tumors harbor a constellation of genomic alterations that may dictate their clinical behavior and treatment response. Blood-based biomarker testing options like FoundationOneLiquid CDx can help expand access to genomic insights in patients with advanced cancer as compared to a tissue biopsy, which may not be an option for many patients due to reasons such as tumor location and patient's health status. FoundationOneLiquid CDx is a single non-invasive test based on Next Generation Sequencing techn

Pfizer moves US court against Aurobindo Pharma, Dr Reddy's on cancer drug

HYDERABAD: Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance ( palbociclib ) before expiration of its patent. Pfizer filed the possible patent infringement petition against both the companies in the United States District Court for the District of Delaware on two counts last week. Palbociclib is used to treat a certain type of breast cancer and works by slowing or stopping the growth of cancer cells. Ibrance clocked nearly $5 billion revenues globally including $3.25 billion in the USA in 2019, according to Pfizer's 2019 annual report. In March 2019, several generic companies notified us that they had filed abbreviated new drug applications with the US Food and Drug Administration (FDA) seeking approval to market generic versions of Ibrance. The generic co

Natco Pharma’s partner gets US FDA nod for cancer treatment drug

Natco Pharma said its marketing partner Breckenridge Pharmaceutical has received final approval from the US health regulator for pomalidomide capsules, treatment of patients suffering from multiple myeloma cancer. Breckenridge Pharmaceutical has received final approval for its abbreviated new drug application (ANDA) for Pomalidomide Capsules from the US Food and Drug Administration (US FDA),” Natco Pharma said in a regulatory filing. In addition, Natco and Breckenridge have settled the patent litigation with Celgene (now part of Bristol-Myers Squibb) in the US district court for this product, the company added. The company, however, did not share details of the settlement. Celgene sells Pomalidomide Capsules under Brand name Pomalyst in the US market which is indicated for the treatment of patients suffering from multiple myeloma cancer. Natco Pharma said as per industry sales data, Pomalyst had annual sales of $957 million during the twelve months ending September 2020. Source:https:/

Merck, Eisai announce phase 3 KEYNOTE-581/CLEAR trial of Keytruda plus Lenvima demonstrated statistically significant improvement in PFS, OS and ORR versus sunitinib to treat advanced RCC

  Merck and Eisai announced new investigational data demonstrating positive top-line results from the pivotal phase 3 KEYNOTE-581/CLEAR trial (Study 307). In the trial, the combinations of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, and Lenvima plus everolimus were evaluated versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Keytruda plus Lenvima met the trial’s primary endpoint of progression-free survival (PFS) and its key secondary endpoints of overall survival (OS) and objective response rate (ORR), demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat (ITT) study population. Lenvima plus everolimus also met the trial’s primary endpoint of PFS and a key secondary endpoint of ORR, demonstrating a statistically significant and clinically meaningful improveme

Merck to Acquire VelosBio

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and VelosBio Inc. today announced that the companies have entered into a definitive agreement pursuant to which Merck, through a subsidiary, will acquire all outstanding shares of VelosBio for $2.75 billion in cash, subject to certain customary adjustments. VelosBio is a privately held clinical-stage biopharmaceutical company committed to developing first-in-class cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). VelosBio’s lead investigational candidate is VLS-101, an antibody-drug conjugate (ADC) targeting ROR1 that is currently being evaluated in a Phase 1 and a Phase 2 clinical trial for the treatment of patients with hematologic malignancies and solid tumors, respectively. “At Merck, we continue to bolster our growing oncology pipeline with strategic acquisitions that both complement our current portfolio and strengthen our long-term growth potential,” said Dr. Roger M. Perlmutte

MedGenome launches Tumor Mutation Burden test for better understanding of immuno-therapy

MedGenome Labs, a genomics-driven research and diagnostics company, launched Tumor Mutation Burden (TMB) test to help clinicians take informed decision on immuno-therapy for their cancer patients. Immuno-therapy is a concept in cancer treatment, where the approach is to use body's immune system to kill the cancer cells. A crucial aspect of success of tumor mutation burden test is that the body's immune system should differentiate cancer cells and normal cells. TMB is defined as the total number of nonsynonymous mutations in the tumor exome. Tumor cells are genetically unstable and harbor high levels of somatic mutations which may result in the expression of neoantigens. The presentation of tumor-specific neoantigens on major histocompatibility complex molecules is essential for the recognition of tumors by the T-cells of the immune system. This induces a T-cell response towards patient-specific neoantigens. These tumors may be eligible to successful immune-mediated destruction