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FDA Granted Accelerated Approval To Belantamab Mafodoti...

(FDA.gov) Aug 6, 2020 - On August 5, 2020, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for ...

Adaptive Biotechnologies Receives Expanded FDA Clearanc...

(Adaptive Biotech) Aug 6, 2020 - First and only FDA-cleared assay for MRD in CLL, multiple myeloma and ALL. CLL clearance includes testing...

Featured Content

Nancy Lin, MD, on impressions of the Phase 2 study done the by the Translational Breast Cancer Consortium

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center, and Sara Hurvitz, MD, Associate Professor of Medicine, Geffen School of Medicine, UCLA, Medical Director, Jonsson Comprehensive Cancer Center Clinical Research Unit, discuss breast cancer patient types, challenges, and treatment advances.

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.

A lack of interoperability in the nation's healthcare system has detracted from patient care, leading to poor health outcomes and higher medical expenditures. A new CMS Rule aims to break down barriers and develop technology-based solutions to improve interoperability and enable better access to patient electronic healthcare information.

OBR spoke at length with ASCO's president, Dr. Howard "Skip" Burris, about the pros and cons of ASCO20's virtual format and how it may influence the paradigm for future ASCO annual meetings. In addition, he gave us the scoop on the upcoming ASCO20 Education Program, scheduled to take place from August 8 to August 10.

Podcasts

Breast Cancer - Sara Hurvitz, MD, and Robert Figlin, MD, discuss recent clinical developments in early stage and late stage breast cancer

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Adjuvant Lung Cancer - Roy Herbst, MD, and Robert Figlin, MD, discuss the recent ASCO20 plenary presentation of the A...

06/25/20

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

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Robert Dreicer, MD, updates us on the role of cabazitaxel from the CARD study

Derek Raghavan, MD, discusses Mobile screening Chest CT project for use in underserved populations

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July 2020 Edition

OBR spoke at length with ASCO's president, Dr. Howard "Skip" Burris, about the pros and cons of ASCO20's virtual format and how it may influence the paradigm for future ASCO annual meetin...

July 2020 Edition

A lack of interoperability in the nation's healthcare system has detracted from patient care, leading to poor health outcomes and higher medical expenditures. A new CMS Rule aims to break...

July 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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The Oncology Business Dynamics Learning Platform addresses the need to have a high level of understanding of the non-clinical issues that are influencing the decision making process for hem/oncs today.

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Oncology Events Calendar

August 8 - 10, 2020

Virtual ASCO20 Education Program

N/A

August 14, 2020

2020 SNO Virtual Conference on Brain Metastases (Society for Neuro-Oncology) (in association with the AANS/CNS Section on Tumors)

[Virtual Format]

August 17 - 18, 2020

Virtual SSO 2020 – International Conference on Surgical Cancer Care (Society of Surgical Oncology)

N/A

August 18, 2020

Highlights from the 2020 ASCO Annual Meeting: Part II of Your Guide to the Latest Cancer Research and Treatment (CancerCare Connect Education Workshop)

(by phone or via webcast)

August 21 - 23, 2020

Coping with Metastatic Triple Negative Breast Cancer: Part I of Life with Metastatic Triple Negative Breast Cancer (CancerCare Connect Education Workshop)

(by phone or via webcast)

October 15-17, 2020

Caregiving for Your Loved One Living with Metastatic Triple Negative Breast Cancer: Part II of Life with Metastatic Triple Negative Breast Cancer (CancerCare Connect Education Workshop)

(by phone or via webcast)

November 3, 2020

OBR Radar

Top 5 Market Moving Events

Date	Company and Product
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.
Oct 18	Roche, Perjeta® (pertuzumab) + Herceptin® (trastuzumab) Roche announced on Feb. 25, 2020 that the FDA had accepted its Biologics License Application (BLA) for the fixed-dose combination (FDC) of pertuzumab and trastuzumab with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. The fixed-dose combination is administered under the skin in just minutes, compared to hours with intravenous administration, significantly reducing the time spent receiving treatment for patients. The BLA for the FDC is based on results from the phase 3 FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy. The FDC of Perjeta and Herceptin is a new SC formulation that combines Perjeta and Herceptin with Halozyme Therapeutics’ Enhanze drug delivery technology. U.S. regulators are expected to make an approval decision on the FDC by Oct. 18, 2020.
Oct 30	Merck , Keytruda® (pembrolizumab) The company said on July 8, 2020 that the FDA had accepted and granted priority review to the sBLA for Keytruda as monotherapy for adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). The application is based on data from the pivotal phase 3 KEYNOTE-204 trial comparing Keytruda to brentuximab vedotin (BV), a current standard of care in this patient population. In the trial, Keytruda demonstrated a significant improvement in progression-free survival (PFS) compared to BV. The FDA has set a PDUFA, or target action date of Oct. 30, 2020 for a decision on the new indication. KEYNOTE-204 is also serving as the confirmatory trial for the Keytruda's accelerated approval hematology indications.