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FDA Says To Review Side Effect Of GSK's Multiple Myelom...

(Reuters) July 10, 2020 - The U.S. Food and Drug Administration on Friday said it would review GlaxoSmithKline’s experimental treatment for ...

Largest-Ever Study of Prostate Cancer Genomics in Black...

(UCSF) July 10, 2020 - Black patients should also benefit from recently approved PARP inhibitor therapies "if applied equitably," study finds....

Featured Content

Joyce Liu, MD, summarizes the outcomes of the NRG-GY004 phase III study regarding ovarian cancer

Roy Herbst, MD, and Robert Figlin, MD, discuss the implications of the ADAURA study investigating the use of Tagrisso (osimertinib) in stage I-III EGFR+ NSCLC patients

A panel of three gastrointestinal experts from the City of Hope, the Mayo Clinic, and Duke University Medical Center, led by Charles H. Weaver, MD, shared their perspectives on a key take-away emerging from several high-profile studies at ASCO 2020: less is more when it comes to chemotherapy management in treating colorectal cancer. The panel discussed h...

At ASCO’s first virtual meeting, a handful of studies featured potentially practice-changing data. Among the studies were the BOSTON trial of selinexor, which delayed disease progression and neuropathy in multiple myeloma patients, and CheckMate 9LA, a possible win for non-small cell lung cancer patients using the first-line immunotherapy combo of nivol...

A report on several promising studies at ASCO 2020 focused on personalized therapies for patients with unmet needs. Included are phase 2 studies in gastric, colorectal, and lung cancer that may expand the use of the antibody-drug conjugate Enhertu, and encouraging data for cell-based therapies for two incurable hematologic malignancies.

A panel of three breast cancer experts looked at some of the big studies at ASCO 2020 and discussed treatment advances and setbacks of key data in the area of CDK4/6 inhibition, HER2-positive disease, and immunotherapy in breast cancer at a roundtable.

Podcasts

Adjuvant Lung Cancer - Roy Herbst, MD, and Robert Figlin, MD, discuss the recent ASCO20 plenary presentation of the ADAURA study investigating the use of Tagrisso (osimertinib) in stage I-III EGFR+ NSCLC patients

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Breast Cancer – Nancy Lin, MD, and Robert Figlin, MD, discuss novel agents and recent clinical developments in ...

06/12/20

Non Small Cell Lung Cancer (NSCLC) – Edward Garon, MD, and Robert Figlin, MD, discuss promising agents in devel...

06/11/20

Colon and Rectal Cancer – David Ilson, MD, and Robert Figlin, MD, discuss recent clinical advances in colon and...

06/08/20

Waldenstrom macroglobulinemia - Constantine Tam, MD, and Robert Figlin, MD, discuss recent clinical advances in the t...

06/08/20

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Debra Patt, MD, offers opinion on whether embracing informatics is worth the financial investment

Nicholas Vogelzang, MD, FASCO, FACP, considers the dosing effects of cabazitaxel in clinical studies

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June 2020 Edition

A panel of three gastrointestinal experts from the City of Hope, the Mayo Clinic, and Duke University Medical Center, led by Charles H. Weaver, MD, shared their perspectives on a key take...

June 2020 Edition

At ASCO’s first virtual meeting, a handful of studies featured potentially practice-changing data. Among the studies were the BOSTON trial of selinexor, which delayed disease progressio...

June 2020 Edition

A report on several promising studies at ASCO 2020 focused on personalized therapies for patients with unmet needs. Included are phase 2 studies in gastric, colorectal, and lung cancer th...

June 2020 Edition

A panel of three breast cancer experts looked at some of the big studies at ASCO 2020 and discussed treatment advances and setbacks of key data in the area of CDK4/6 inhibition, HER2-posi...

Blog

ASCO 2020 Highlights for Sunday

May 31, 2020

Sunday’s live broadcast of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting featured late-breaking data fr...

ASCO 2020 Highlights for Saturday

May 30, 2020

The live broadcast of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting kicked off this morning with highligh...

Sneak Peek at ASCO 2020 Plenary Sessions

May 29, 2020

Ahead of this weekend’s live broadcast of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, late-breaking ...

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Oncology Events Calendar

July 14, 2020

Oncologic Drugs Advisory Committee (ODAC) Meeting re: BLA for GlaxoSmithKline's belantamab mafodotin with a proposed indication of relapsed or refractory multiple myeloma

[via online teleconference]

July 15, 2020

OBR Radar

Top 5 Market Moving Events

Date	Company and Product
Jul 14	GlaxoSmithKline / Seattle Genetics, belantamab mafodotin (GSK2857916) GSK said on June 19, 2020 that a virtual Oncologic Drugs Advisory Committee (ODAC) would meet on July 14, 2020 to review the Biologics License Application (BLA) for belantamab mafodotin as a potential treatment for patients with relapsed or refractory multiple myeloma (r/r MM) who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The BLA was granted Priority Review status by the FDA in January 2020 based on data from the pivotal phase 2 DREAMM-2 study which enrolled heavily pre-treated patients with actively progressing MM that had worsened despite current standard of care. Results from that trial, published in The Lancet in Dec. 2019, showed that among 97 patients receiving the drug at 2.5mg/kg and 99 receiving it at 3.4mg/kg, respectively 31% and 34% achieved a response to therapy. Follow-up data were also presented at ASCO 2020. Belantamab mafodotin, a potential first-in-class, humanised, anti-BCMA (antibody drug conjugate against B-cell maturation antigen), received Breakthrough Therapy Designation in 2017, and is not currently approved for use anywhere in the world. A Marketing Authorisation Application (MAA) is currently under review by the European Medicines Agency for the same indication. At the JP Morgan Healthcare conference in January 2020, the company said it anticipated that the FDA would rule on the drug in the first half of the year.
Aug 10	Gilead / Kite, KTE-X19 Kite, a Gilead Company, announced on Feb. 10, 2020 that the FDA had accepted the BLA and granted priority review designation for KTE-X19, its investigational CAR T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The marketing application is supported by data from the phase 2 ZUMA-2 trial, which showed that 93% of patients responded to a single infusion of KTE-X19, including 67% of patients who achieved a complete response, as assessed by an Independent Radiologic Review Committee (median follow-up of 12.3 months). Detailed findings from the trial were presented during an oral session at the 2019 ASH annual meeting. The PDUFA, or target action date, is Aug. 10, 2020. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and is not yet approved in any country globally.
Aug 10	Fennec Pharmaceuticals , Pedmark™ (sodium thiosulfate) The company announced on Apr. 13, 2020 that the FDA had accepted for filing and granted Priority Review to the NDA for Pedmark, its investigational drug for the prevention of ototoxicity, or hearing loss, induced by cisplatin chemotherapy in patients one month to <18 years of age with localized, non-metastatic, solid tumors. The FDA has set a PDUFA target action date of August 10, 2020 for an approval decision. If it is approved, Pedmark, a unique formulation of sodium thiosulfate, would be the first product approved for the prevention of cisplatin-induced hearing loss in children. Pedmark has received Breakthrough Therapy and Fast Track Designation from the FDA, in addition to Orphan Drug Designation in the U.S. for its potential indication. The European Medicines Agency (EMA) is also currently reviewing the company's marketing application.
Aug 11	Astex Pharmaceuticals , Oral C-DEC (cedazuridine + decitabine) Astex Pharmaceuticals, a subsidiary of Japan-based Otsuka Pharmaceutical Co. Ltd., announced on Feb. 11, 2020 that the FDA had accepted for Priority Review its NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML). The NDA submission is based on data from the ASCERTAIN phase 3 study which evaluated the 5-day decitabine exposure equivalence of oral C-DEC and IV decitabine. C-DEC is a novel, orally administered fixed dose combination of cedazuridine, an inhibitor of cytidine deaminase, with the anti-cancer DNA hypomethylating agent, decitabine. Oral C-DEC is an investigational compound and is not currently approved in any country. If it is approved, oral C-DEC has the potential to become the first approved orally administered hypomethylating agent for MDS and CMML in the U.S. Based on a 6-month priority review, it is estimated that U.S. regulators should be making an approval decision on the therapy by Aug. 11, 2020. As previously announced, subject to regulatory approvals, commercialization of oral C-DEC in the U.S. and Canada will be conducted by Taiho Oncology, Inc. and Taiho Pharma Canada. Taiho is a member of the Otsuka group of companies.
Sep 30	Mesoblast Ltd., Ryoncil™ (remestemcel-L) The company announced on Apr. 1, 2020 that the FDA had accepted for priority review the BLA filing for Ryoncil, its allogeneic (off-the-shelf) cell therapy for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA set a PDUFA action date of Sept. 30, 2020. The FDA said that it plans to hold an Advisory Committee Meeting to discuss the application. There are currently no FDA-approved treatments in the U.S. for children under 12 with SR-aGVHD. Mesoblast's lead pipeline candidate, Ryoncil is comprised of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor, and is administered to patients in a series of intravenous infusions. If approved, the company will make the therapy immediately available in the U.S.