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umbralisib (TGR-1202) / TG TherapeuticsTG Therapeutics Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma (GlobeNewswire) - Jun 17, 2020 - "TG Therapeutics, Inc…announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting accelerated approval of umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL)."Keytruda (pembrolizumab) / Merck (MSD)FDA Approves Second Biomarker-Based Indication for Merck’s KEYTRUDA (pembrolizumab), Regardless of Tumor Type (Businesswire) - Jun 17, 2020 - "Merck…announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options...The FDA also approved FoundationOne® CDx test as the companion diagnostic to identify patients with solid tumors that are TMB-H (≥10 mutations/ megabase) who may benefit from immunotherapy treatment with KEYTRUDA monotherapy….The accelerated approval was based on data from…KEYNOTE-158 (NCT02628067), a multicenter, non-randomized, open-label trial evaluating KEYTRUDA (200 mg every three weeks)."HB-201 / Hookipa Pharma; HB-202 / Hookipa PharmaHOOKIPA Announces FDA Clearance of its IND Application for HB-202/201 Clinical Trial to Treat HPV-Positive Cancers (GlobeNewswire) - Jun 17, 2020 - "HOOKIPA Pharma Inc…announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application for HB-202. This IND allows HOOKIPA to initiate an additional arm in its Phase 1/2 clinical trial for HB-201 (NCT04180215) for the treatment of Human Papillomavirus 16-positive (HPV 16+) cancers…In 2021, HOOKIPA expects to also combine HB-202/201 with an approved checkpoint inhibitor…'look forward to treating the first HB-202/201 patient later this year.'"
