Blog Exposure - FDA Granted Priority Review to Novartis’ Kymriah(TM) for Adults with relapsed/refractory B-cell lymphoma
LONDON, UK / ACCESSWIRE / January 19, 2018 /Active-Investors.com has just released a free research report on Novartis AG (NYSE: NVS). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=NVS as the Company's latest news hit the wire. On January 17, 2018, the Company declared that the US Food and Drug Administration (FDA) has granted Priority Review to Kymriah™ (tisagenlecleucel) suspension for intravenous infusion, for the treatment of adult patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT). A Supplemental Biologics License Application (sBLA) for Kymriah™ was submitted to FDA on October 31, 2017. Register today and get access to over 1,000 Free Research Reports by joining our site below:
Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Novartis AG most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
EMA Granted Accelerated Assessment for Kymriah™ in Children and Young Adults with r/r B-Cell ALL and r/r DLBCL
Novartis also announced that the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Authorization Application (MAA) for Kymriah™ for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r DLBCL who are ineligible for ASCT. The Company submitted MAA to EMA for Kymriah™ in November 2017.
Priority Review designations are intended to make a decision on an application within six months instead of the normal 10 months. If approved by the FDA and EMA, Kymriah™ would represent the first chimeric antigen receptor T cell (CAR-T) therapy available for two distinct indications in non-Hodgkin lymphoma and B-cell ALL. CAR-T therapy is a breakthrough in hematologic cancer treatment in which a patient's own T cells are engineered to seek and destroy cancer cells.
Kymriah™ Received First FDA Approval for B-cell Acute Lymphoblastic leukemia in 2017
On August 30, 2017, FDA approved Kymriah™ suspension for intravenous infusion, the first CAR-T therapy, for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse.
Novartis Plans Additional Regulatory Submissions for Kymriah™ Beyond the US and EU in 2018
The regulatory applications in the US and EU are based on data from the Novartis-sponsored global clinical trial program of Kymriah™. Results from the pivotal phase II JULIET clinical trial served as the basis of the sBLA and MAA for Kymriah™ in adult patients with r/r DLCBL. The updated results from the JULIET clinical trial were declared in December 2017. Results from the pivotal phase II ELIANA study were submitted as part of the MAA for Kymriah™ in children and young adults with r/r B-cell ALL. Novartis plans additional regulatory submissions for Kymriah™ in pediatric and young adult patients with r/r B-cell ALL and adult patients with r/r DLBCL beyond the US and EU in 2018.
Kite's Yescarta™ Became First CAR-T Therapy Approved by FDA for Treatment of Adult Patients with B-Cell Lymphoma
On October 18, 2017, Kite, a Gilead Company, announced that the FDA granted regular approval to Yescarta™ (axicabtagene ciloleucel), the first CAR T therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL, not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Kymriah™ is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer. Kymriah™ uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular expansion and persistence. Kymriah™ may cause side effects that are severe or life-threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Other common side effects include high fever, chills/shaking chills, severe nausea, vomiting, and diarrhea, severe muscle or joint pain, very low blood pressure, and dizziness/lightheadedness.
About B cell lymphoma and lymphoblastic leukemia
Diffuse large B cell lymphoma (DLBCL) is a cancer of B cells, a type of white blood cell responsible for producing antibodies. It is the most common type of non-Hodgkin lymphoma among adults, occurring primarily in older individuals, with a median age of diagnosis at approximately 70 years of age.
Acute lymphoblastic leukemia (ALL) is a cancer of the lymphoid line of blood cells characterized by the development of large numbers of immature lymphocytes. Symptoms may include tiredness, pale skin color, fever, easy bleeding or bruising, enlarged lymph nodes, or bone pain.
About Novartis AG
Founded in 1996 and headquartered in Basel, Switzerland, Novartis AG is a pharmaceutical company researching, developing, manufacturing, and marketing healthcare products worldwide. The Company uses science-based innovation to address some of society's most challenging healthcare issues.
Stock Performance Snapshot
January 18, 2018 - At Thursday's closing bell, Novartis AG's stock slightly fell 0.54%, ending the trading session at $86.41.
Volume traded for the day: 1.52 million shares.
Stock performance in the last month – up 1.83%; previous three-month period – up 0.08%; past twelve-month period – up 20.20%; and year-to-date - up 2.92%
After yesterday's close, Novartis AG's market cap was at $222.86 billion.
Price to Earnings (P/E) ratio was at 30.71.
The stock has a dividend yield of 3.15%.
The stock is part of the Healthcare sector, categorized under the Drug Manufacturers - Major industry. This sector was flat at the end of the session.
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