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FDA Nod For AGIO's AML Drug, 2nd Neupogen Biosim Gets Green Light, BGNE On Watch

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Today's Daily Dose brings you news about FDA approval of Agio's Tibsovo for refractory acute myeloid leukemia; BeiGene's encouraging preliminary topline results from its pivotal phase II trial of Tislelizumab in relapsed/refractory classical Hodgkin's lymphoma, and U.S. regulatory nod for Pfizer's fourth biosimilar.

Read on...

The FDA has approved Agios Pharmaceuticals Inc.'s (AGIO) Tibsovo 250 mg tablets (Ivosidenib) for treating relapsed or refractory acute myeloid leukemia patients with an IDH1 mutation, nearly one month ahead of the expected decision date.

Isocitrate dehydrogenase (IDH) 1 and 2 are metabolic enzymes that are mutated in a wide range of blood and solid tumor cancers.

Acute myelogenous leukemia (AML) is a cancer of blood and bone marrow characterized by rapid disease progression. AML Patients with IDH1 and IDH2 mutations represent about 20% of all patients with AML.

Agios has an exclusive collaboration and license agreement with China's CStone Pharmaceuticals to develop and commercialize Tibsovo in Mainland China, Hong Kong, Macau and the Taiwan territory for leukemia indications. All rights to the drug in the rest of the world are retained by Agios.

The approval of Tibsovo was based on phase I study results.

Agios and Celgene already market Idhifa (enasidenib), a drug to treat AML patients with an isocitrate dehydrogenase-2 (IDH2) mutation.

AGIO closed Friday's trading at $91.06, down 0.13%.

BeiGene Ltd. (BGNE) has reported encouraging preliminary topline results from its pivotal phase II trial of Tislelizumab in Chinese patients with relapsed/refractory classical Hodgkin's lymphoma (R/R cHL).

The single-arm pivotal trial enrolled 70 patients with classical Hodgkin's lymphoma who either failed autologous stem cell transplantation (ASCT) or who were ineligible for ASCT.

According to the trial data, the overall response rate was 73 percent, including 50 percent complete response rate. The median duration of response had not been reached.

BeiGene's expects to file Biologics License Application for Tislelizumab in relapsed/refractory classical Hodgkin's lymphoma (R/R cHL) with the China Drug Administration (CDA) later this year.

In other news, the Company announced that it is preparing to submit in the first half of 2019 a New Drug Application to pursue an accelerated approval of Zanubrutinib for patients with Waldenström Macroglobulinemia based on results from the global Phase 1 study. The mature data from the phase I study are expected this fall.

BGNE closed Friday's trading at $169.23, up 3.12%.

Corbus Pharmaceuticals Holdings Inc.'s (CRBP) drug candidate Lenabasum has been granted Orphan Drug Designation by the FDA for the treatment of dermatomyositis.

Dermatomyositis is a rare chronic systemic autoimmune disease characterized by inflammation of muscles and skin, affecting roughly 80,000 in the US, EU and Japan and has a 5-year mortality rate as high as 30%.

Lenabasum has demonstrated clinical benefit and positive impact on inflammatory and immunological markers in Phase 2 studies in diffuse cutaneous systemic sclerosis, dermatomyositis and cystic fibrosis, according to the Company.

CRBP closed Friday's trading at $5.35, down 1.83%.

The FDA has approved Pfizer Inc.'s (PFE) NIVESTYM, a biosimilar to Amgen's Neupogen. The approval marks Pfizer's fourth biosimilar to be approved by the FDA and the second Neupogen biosimilar in the U.S.

NIVESTYM has been approved for the same five indications as Neupogen, the reference product.

NIVESTYM is indicated:

-- To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
-- For reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
-- To reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
-- For the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
-- For chronic administration to reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.

The first biosimilar to Amgen's Neupogen that won FDA approval is Sandoz Inc.'s Zarxio. It was greenlighted in the U.S. in March 2015.

PFE closed Friday's trading at $37.33, down 0.08%.

SELLAS Life Sciences Group Inc.'s (SLS) lead drug candidate, Galinpepimut-S, for the treatment of multiple myeloma has received Fast Track Designation from the FDA.

Galinpepimut-S is under phase II trial in the treatment of high-risk multiple myeloma.

SLS closed Friday's trading at $1.55, up 3.33%.

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