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ZURICH, (Reuters) - Roche (ROG.S) is launching a new genomic profiling kit that lets cancer researchers explore tumours without having to send tissue samples to centralised laboratories, the Swiss drugmaker said on Monday. The AVENIO Tumour Tissue Comprehensive Genomic Profiling (CGP) Kit was developed with Roche unit Foundation Medicine, a molecular information specialist whose products help doctors match patients to appropriate therapies and clinical trials. "The Kit complements the current CGP portfolio offered by Roche and Foundation Medicine and allows laboratories to expand their oncology research in-house," Roche said in a statement, giving no financial information about the product. "Ultimately, a future version of the kit may lead to additional resources for clinicians to use in the diagnosis and treatment of cancer." Source:https://www.reuters.com/business/healthcare-pharmaceuticals/roche-launches-genomic-profiling-kit-ease-cancer-research-2021-10-25/

AstraZeneca announces positive high-level results from the TOPAZ-1 phase III trial showed Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone as a 1st-line treatment for patients with advanced biliary tract cancer (BTC). At a predefined interim analysis, the Independent Data Monitoring Committee concluded that the trial met the primary endpoint by demonstrating an improvement in OS in patients treated with Imfinzi plus chemotherapy versus chemotherapy alone. The combination also demonstrated an improvement in progression-free survival (PFS) and overall response rate, key secondary endpoints. Imfinzi plus chemotherapy was well tolerated, had a similar safety profile versus the comparator arm and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone. BTC is a group of rare and aggressive cancers that occu...

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, in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] =1)as determined by an FDA-approved test. The approval is based on the phase 3 KEYNOTE-826 trial evaluating Keytruda plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without bevacizumab, compared to the same chemotherapy regimens, with or without bevacizumab. In this patient population, Keytruda plus chemotherapy, with or without bevacizumab, demonstrated superior overall survival (OS; HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (PFS; HR=0.62 [95% CI, 0.50-0.77]; p<0.0001) compared to chemotherapy, with or without bevacizumab, in patients whose tumors exp...

The US Food and Drug Administration (FDA) has approved Eli Lilly and Company's Verzenio (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of =20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. Verzenio is the first and only CDK4/6 inhibitor approved for this patient population. "Over time, the collective results of the Verzenio clinical development programme have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options," said Jacob Van Naarden, senior vice president,...

Merck, known as MSD outside the United States and Canada, announced that the phase 3 KEYNOTE-394 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in Asian patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib met its primary endpoint of overall survival (OS). The study found that treatment with Keytruda plus best supportive care resulted in a statistically significant improvement in OS compared with placebo plus best supportive care. KEYNOTE-394 also met its key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR), with statistically significant improvements for Keytruda compared with placebo. No new safety signals were observed. These results will be presented at an upcoming medical meeting. “Frequently diagnosed at an advanced stage, hepatocellular carcinoma has one of the highest mortality rates of solid cancers. Despite recent progress, there remains an unmet need for anti-PD-1 monotherapy after sorafenib...

Drug firm BDR Pharmaceuticals on Tuesday said it has launched generic Cabozantinib, used for the treatment of various types of cancer , and will bring the product in India in the next few days. Cabozantinib is used for the treatment of metastatic medullary thyroid cancer, advanced renal cell carcinoma and hepatocellular carcinoma, BDR Pharma said in a statement. “Ensuring that all our patients have access to quality-produced, world-class treatment at a reasonable rate was the main reason for launching the drug in India,” BDR Pharmaceuticals, Business Development – Director, Raheel Shah said. The company, however, did not give any details about the cost of the drug. Cabozantinib is prescribed for treating patients with progressive, metastatic medullary thyroid cancer and as a second-line treatment for renal cell carcinoma apart from treating hepatocellular carcinoma, BDR Pharma said. The drug is available in the strengths of 20 mg, 40 mg and 60 mg, it added. Source:https://indianexpres...

MSN Labs has launched Cabolong, a branded generic of Cabozantinib, for the treatment of renal cell carcinoma. Cabolong is available in 20mg/40mg/60mg strengths at a pricing of below ₹10,000 for monthly treatment regimen with the highest strength. In contrast, the same therapy cost runs into lakhs (of rupees) with imported brands currently available in the market, the company said in a release on Thursday. MSN Labs said it has set up a dedicated oncology division, whose focus is on presenting a comprehensive range of affordable high quality, bio-equivalent generic oncology medicines to benefit patients in India. “Given the rising cancer incidence in our country and overwhelming treatment costs, launch of our dedicated oncology division demonstrates our unwavering commitment to patients’ health and economic well-being,” it said. Cabolong is manufactured at MSN Labs facility approved by global regulatory authorities such as US FDA and EU GMP, the company said. Source:https://www.thehindu....

  Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022. “Although we’ve seen significant advances in the treatment of melanoma since the introduction of immune checkpoint inhibitors, there continue to be patients who could benefit from a novel dual immunotherapy approach,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb. “Based on the results of the RELATIVITY-047 trial, we believe that the relatlimab and nivolumab fixed-dose combination has the potential to improve outcomes for patients with metasta...

  Boehringer Ingelheim announced the acquisition of Abexxa Biologics, a biopharmaceutical company taking a new approach in the fields of immuno-oncology and oncology research to develop the next generation of precision medicines designed to revolutionize cancer treatments. The acquisition will allow Boehringer Ingelheim to access Abexxa’s expertise in targeting cancer-specific proteins that are located inside the cell, rather than those expressed on the cell membrane. This enlarges the pool of potential cancer antigen targets. In particular, Abexxa’s technology could lead to the development of cancer immunotherapies that are effective in a broader range of patients and cancer types. “The acquisition of Abexxa bolsters our commitment to tumor-antigen discovery and new ways of targeting intracellular antigens. Their cutting-edge know-how and technologies for antigen discovery and novel antibody generation strongly complement the current approaches we have been applying successfully t...

  Merck announced the final overall survival (OS) results from the pivotal phase 3 KEYNOTE-355 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel, nab-paclitaxel or gemcitabine/carboplatin) for the first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC). Keytruda is the first anti-PD-1 therapy in combination with chemotherapy to demonstrate a statistically significant and clinically meaningful improvement in OS for these patients. In this study, Keytruda plus chemotherapy reduced the risk of death by 27% (HR=0.73 [95% CI, 0.55-0.95]; p=0.0093) in patients with mTNBC whose tumors expressed PD-L1 (Combined Positive Score [CPS] =10), as compared to chemotherapy alone. There was an increase of 6.9 months in median OS with Keytruda plus chemotherapy compared to chemotherapy alone (23.0 months [95% CI, 19.0-26.3] vs. 16.1 months [95% CI, 12.6-18.8], respectively). Although the trial was not powered to compa...

GlaxoSmithKline (GSK) plc will present new data across the company’s oncology pipeline and portfolio at the upcoming European Society for Medical Oncology (ESMO) Congress 2021 (16-21 September), including new data on Jemperli (dostarlimab) and Zejula (niraparib), as well as early-stage research in immuno-oncology and oncology cell therapy. With 13 presentations at the meeting (12 GSK-sponsored and one GSK-supported), GSK will demonstrate its momentum in advancing dostarlimab and niraparib, and provide new insights into investigational therapies through early-stage research. The data being presented at ESMO reflect GSK’s commitment to strengthening its oncology pipeline across its focus areas of immuno-oncology, synthetic lethality and oncology cell therapy. GSK has a diverse portfolio and pipeline, including three marketed oncology medicines and 16 assets in clinical development that leverage the science of the immune system, human genetics and advanced technologies to address a variet...

4baseCare, a precision oncology company in India, launched their product - TARGT Indiegene, India's largest and first population-specific tumour gene panel derived from Whole Exome and Whole Transcriptome data of over 1,500 cancer patients across 28 different cancer types. Most of the patients were presented with stage III/IV disease, and presented with disease progression and had exhausted all the options in the standard of care. Most of the cancer panels currently available in the market are based on data from the Caucasian population, and the same panel is used for testing across all the geographies. For example, the TARGT Indiegene' cancer panel is based on insights generated from tumour tissues of Indian cancer patients resulting in better success rates using precision medicine in the management of cancer. The insights from research have helped build the largest resource of mutational signatures identified in cancer patients in India. Research has provided insights into 1,...

First-of-its-kind initiative provides patients in India with access to remote opinions and consultations, using technology from India-based telemedicine provider iCliniq Physical location in Chennai , India will serve as a telemedicine hub to coordinate with Memorial Sloan Kettering Cancer Center specialists NEW YORK and CHENNAI , India , Aug. 2, 2021 /PRNewswire/ -- Memorial Sloan Kettering Cancer Center, the world's oldest and largest private cancer center, has launched MSKCC India to provide cancer patients in India with access to the institution's world-renowned oncologists, research, clinical trials, and education. The effort stems from the institution's core mission of advancing transformative cancer care through education and research worldwide. As part of this first-of-its-kind offering, MSKCC India will provide remote opinions via video or written consultations. A Memorial Sloan Kettering Cancer Center oncologist who specializes in a patient's form of...

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 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...

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 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 m...

  Novartis announced robust data from the primary analysis of the pivotal phase II ELARA trial of Kymriah (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL). Data will be presented as an oral presentation during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting (Abstract #7508; oral presentation: Monday, June 7, 10:30 AM CDT). “Patients with follicular lymphoma who do not respond to their current treatment or who relapse early after treatment often have to endure multiple treatments, which can result in diminished clinical outcomes with each successive therapy,” said Stephen J. Schuster, MD, the Robert and Margarita Louis-Dreyfus Professor in Chronic Lymphocytic Leukemia and Lymphoma Clinical Care and Research in Penn’s Perelman School of Medicine and director of the Lymphoma Program at the Abramson Cancer Center. Schuster will present the results at ASCO. “Our goal as researchers is to continue to explore...