Showing posts from October, 2020

Merck: FDA grants Regeneron, Sanofi's Libtayo priority review for coveted first-line use in lung cancer

One month after Regeneron and Sanofi posted impressive data from a phase 3 trial of their PD-1 inhibitor Libtayo in first-line non-small cell lung cancer (NSCLC), the FDA has shifted the drug into the fast lane—possibly offering the companies a chance to challenge the undisputed leader in that market, Merck’s Keytruda. The FDA has granted priority review to Libtayo for the treatment of patients with locally advanced or metastatic NSCLC whose tumors have levels of biomarker PD-L1 of 50% or more. The agency is set to make its decision by Feb. 28, Regeneron announced . The data supporting the FDA’s decision to speed up the review are impressive, to be sure. In a trial with 710 NSCLC patients, Libtayo slashed the risk of death by 43% among those with PD-L1 levels of 50% or more, when compared to platinum chemotherapy, Sanofi and Regeneron announced during the virtual meeting of the European Society of Medical Oncology (ESMO). In that subset of patients, the risk of disease progression fell

In a first, an Indian startup develops a handheld device for detecting oral cancer

Detection of oral cancer, one of the most common cancers in India, may become easy and affordable with an Indian biomedical startup coming up with a handheld imaging device that can screen and detect tumours in the mouth very early stages. OralScan, designed and developed by Sascan Meditech, a startup incubated at TiMED, a technology business incubator of the Sree Chitra Tirunal Institute for Medical Science and Technology (SCTIMST) in Thiruvananthapuram, would be officially launched by Kerala Health Minister K K Shailaja on Wednesday. OralScan has already undergone multi-centre trials covering six hospitals in the country, and the technology has already received an Indian patent, and a US patent is pending, a statement said on Tuesday. OralScan was conceived and developed with seed funding from the National Initiative for Developing and Harnessing Innovations (NIDHI) scheme of the Department of Science & Technology (DST), Govt of India and was further supported by the Department o

AstraZeneca, Daiichi Sankyo’s Enhertu receives priority review status in US treat HER2-positive metastatic gastric cancer

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Gastric (stomach) cancer is the fifth most common cancer worldwide and the third leading cause of cancer mortality with a five-year survival rate of 5% for metastatic disease; there were approximately one million new cases reported in 2018 and 783,000 deaths. In the US, it is estimated that 27,600 new cases of gastric cancer will be diagnosed in 2020 and more than 11,000 people will die from the disease. For patients with metastatic gastric cancer who progress on initial treatment with an anti-HER2 medicine, there are no other approved HER2-directed medicines. José Baselga, executive vice president, Oncology R&D said, “Once patients with HER2-positive metastatic gastri

Philips showcases integrated radiation oncology solutions to streamline diagnosis and treatment at ASTRO 2020

Amsterdam, The Netherlands – Royal Philips  , a global leader in health technology, will showcase its latest advances in radiation oncology at the American Society for Radiation Oncology (ASTRO) annual meeting (October 24-28). During the virtual event, Philips will showcase its comprehensive portfolio of integrated radiation oncology systems and AI‐powered software that helps radiation oncologists manage complexity and boost efficiencies to accelerate the time from patient referral to treatment. As diagnostic and treatment workloads expand in both volume and complexity, radiation therapy departments are under mounting pressure to provide accurate treatment, while minimizing wait times for patients. Today, the radiation oncology planning process can be labor-intensive, with frequent handovers, long wait times and lags in data transfers between systems. By optimizing workflows, standardizing processes, and providing easy access to relevant patient information, Philips supports care tea

FDA grants fast review for AstraZeneca’s Tagrisso in early-stage lung cancer

The FDA has granted a fast review for AstraZeneca’s Tagrisso oncology drug in certain patients with early-stage lung cancer. Results from the phase 3 ADAURA trial were the talk of this year’s American Society of Clinical Oncology (ASCO) conference in summer and the regulator has granted a Priority Review for a label extension based on the results. The FDA reserves these faster reviews, taking six months at the most instead of the standard ten-month timeframe, for medicines that demonstrate superior efficacy or safety for serious diseases. ADAURA tested Tagrisso (osimertinib) in patients with early-stage (1B, II and III) epidermal growth factor receptor-mutated (EGFR) non-small cell lung cancer (NSCLC) after complete tumour removal. Up to 30% of all patients diagnosed early with NSCLC in this patient group may be diagnosed early enough to have curative surgery, but disease recurrence is common and more than three quarters of patients diagnosed in Stage IIIA experience recurrence withi

BDR Pharma launches Nintenib to treat idiopathic pulmonary fibrosis in India

BDR Pharmaceutical has announced the launch of 100mg and 150 mg nintedanib under the brand name Nintenib for the treatment of idiopathic pulmonary fibrosis (IPF). Nintenib is priced at Rs. 750 (100 mg) and Rs. 900 (150 mg) for a pack of 10 tabs. Idiopathic pulmonary fibrosis (IPF) is a lung disorder where there is scarring of the lungs from an unknown cause. It is usually a progressive disease with a poor long-term prognosi The median survival in IPF patients is 2.5 to 3.5 years. Nintedanib received Drugs Controller General of India (DCGI) approval after showing a significant slowdown in the disease progression in patients with pulmonary fibrosis by reducing the rate of decline in forced vital capacity (FVC) in patients with IPF and mild or moderate lung function impairment. Currently, there are two clinical trials being conducted to study the safety and efficacy of nintedanib for the treatment of moderately to critically ill COVID-19 patients suffering from IPF. Dharmesh Shah, CMD, BD

AstraZeneca Pharma India plans to launch cancer drug; stock opens positive

AstraZeneca Pharma India (AZPIL) announced on Thursday after the market hours that it is planning to launch Acalabrutinib 100 mg capsules, a cancer drug with the name Calquence, on October 21, 2020 in India. Reacting to this news, the stock rose nearly 1.2 per cent during the early trading session on Friday. Acalabrutinib 100 mg capsules (Calquence) are used to treat patients suffering from mantle cell lymphoma (MCL) especially those, who have received at least one prior therapy. It is also used for the treatment of chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). The company is engaged in the business of manufacturing and marketing of pharmaceutical products in healthcare segments namely gastrointestinal, cardiovascular, cancer, respiratory, neurosciences, and infection. On the sales front, the company’s therapeutic area wise revenue break up is 45.2 per cent from cardiovascular drugs, 38.5 per cent from oncology, 14.8 per cent from respiratory and 1.5 per cent fr

Boehringer expands oncology partnership with Oxford BioTherapeutics

Boehringer Ingelheim and Oxford BioTherapeutics Ltd (OBT), a clinical stage oncology company, announced they are building on their successful partnership and are establishing a new alliance to discover additional selective targets for strategic cancer indications to deliver first-in-class treatments for cancer patients. Boehringer Ingelheim will use OBT’s OGAP platform to identify novel target opportunities for new immunotherapies utilizing their T-cell engager, cancer vaccine and oncolytic virus platforms. This follows the initiation of the first patient dosing in a phase 1 clinical trial of a bispecific antibody for the treatment of patients with small cell lung carcinoma and other neoplasms, where the target for the bispecific antibody was discovered during the first phase of the partnership. “This collaboration with Oxford BioTherapeutics is important for advancing therapeutic modalities that depend upon the identification of unique and specific tumor antigens within our cancer im

Pfizer Breast Cancer Drug Fails To Meet Primary Endpoint

The German Breast Group (GBG) and Pfizer Inc. have recently announced that the collaborative Phase 3 PENELOPE-B trial did not meet the primary endpoint of improved invasive disease-free survival (iDFS) in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early breast cancer (eBC) who have residual invasive disease after completing neoadjuvant chemotherapy. No unexpected safety signals were observed.PENELOPE-B is a randomized, double-blind, placebo-controlled Phase 3 study comparing one year of palbociclib plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy. The trial is sponsored by the GBG as part of a clinical research collaboration with Pfizer and other study groups. "Reducing the risk of disease recurrence in patients who have residual disease after neoadjuvant chemotherapy is a complex clinical challenge," said Professor Sibylle Loibl, Chair of

Bristol Myers' Opdivo clears signs of lung cancer in first-in-class pre-surgery win

Bristol Myers Squibb’s Opdivo may not be the most popular immunotherapy for treating metastatic non-small cell lung cancer, but it’s now the first to report positive late-stage clinical results in resectable cases before surgery. Adding Opdivo to standard chemotherapy before surgery helped significantly more non-small cell lung cancer patients show no evidence of cancer cells in their resected tissue compared with chemo alone, BMS said Wednesday. Although detailed data from the ongoing CheckMate-816 trial remain under wraps, BMS was quick to point out that Opdivo was the first immunotherapy to demonstrate an improvement in pathologic complete response for this patient population in a phase 3 trial. But by Evercore ISI analyst Umer Raffat’s estimate, the neoajudvant lung opportunity isn't huge, given that patients would receive only three cycles of Opdivo and that a sizable number of patients do not get any neoadjuvant therapy at all. Still, Opdivo’s PD-1/L1 competitors are eyeing