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FDA Approves the NovoTTF-100LTM System in Combination w...

(Yahoo! Finance) May 23, 2019 - NovoTTF-100L, a Tumor Treating Fields delivery system, is the first FDA-approved mesothelioma treatment in mor...

FDA Alerts Hospitals, Laboratories And Health Care Prof...

(FDA.gov) May 23, 2019 - The U.S. Food and Drug Administration is alerting hospitals, laboratories and providers of a Class 1 recall of Beckma...

Cancer & Blood Specialists of Louisville To Join th...

(AON) May 23, 2019 - American Oncology Network, LLC (AON) is pleased to announce that Cancer & Blood Specialists of Louisville, a leading comm...

Featured Content

Lee Schwartzberg, MD, on how step therapy & utilization management are impacting community oncology

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center and Toni Choueiri, MD, Director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute, discuss Keytruda's approval in renal cell carcinoma (RCC).

At a recent roundtable, three hematology experts discussed treatment trends and recent clinical advances in multiple myeloma (MM). Quadruplet versus triplet drug combinations and the role of stem cell transplant and maintenance therapy were among the topics.

Bo Gamble provided insight at COA 2019 into how commercial payers from large to small are experimenting with new physician payment models in the shift from volume- to value-based reimbursement.

Industry executives at COA 2019 offered their distinct perspectives on assessing drug value, determining drug pricing and evaluating cost for oncology drugs in the current turbulent healthcare marketplace.

At COA 2019, panelists at a session were enthusiastic about how an AI tool, adapted into three practices’ clinical workflows, provided first-hand proof that artificial intelligence could deliver more value-based cancer care in the community oncology setting.

Podcasts

Keytruda RCC Approval/I-O - Toni Choueiri, MD, and Robert Figlin, MD, discuss the recent Keytruda approval in renal cell carcinoma (RCC)

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Renal Cell Carcinoma (RCC) - Rana McKay, MD, and Robert Figlin, MD, discuss clinical highlights from ASCO GU 2019

03/05/19

Colorectal Cancer (CRC) - Axel Grothey, MD, and Robert Figlin, MD, provide clinical update in CRC

03/05/19

Hepatocellular Carcinoma (HCC) - Richard Finn, MD, and Robert Figlin, MD, discuss clinical highlights from ASCO GI 2019

02/13/19

Biliary Tract and GE Junction Cancers - Tanios Bekaii-Saab, MD, FACP, and Robert Figlin, MD, discuss clinical highlig...

02/08/19

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Dan Wygal provides perspective on value-based contracting in oncology

Jax Zummo explains how value-based contracting works

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May 2019 Edition

At COA 2019, panelists at a session were enthusiastic about how an AI tool, adapted into three practices’ clinical workflows, provided first-hand proof that artificial intelligence coul...

May 2019 Edition

Industry executives at COA 2019 offered their distinct perspectives on assessing drug value, determining drug pricing and evaluating cost for oncology drugs in the current turbulent healt...

May 2019 Edition

Bo Gamble provided insight at COA 2019 into how commercial payers from large to small are experimenting with new physician payment models in the shift from volume- to value-based reimburs...

May 2019 Edition

At a recent roundtable, three hematology experts discussed treatment trends and recent clinical advances in multiple myeloma (MM). Quadruplet versus triplet drug combinations and the rol...

Blog

ASCO 2019 Preview

May 15, 2019

In conjunction with the release of the abstracts for the upcoming 2019 ASCO Annual Meeting, a virtual press cast previewed five noteworthy studies that showcase t...

Biosimilars and Interchangeability

May 15, 2019

by Howard Hochster, MD - In 2009 Congress passed the BPCIA (Biologics Price Competition and Innovation Act) to create an approval pathway for biologic compounds, ...

HHS Takes Aim at Rebates, But Will Lower Drug Costs Fol...

Feb 27, 2019

As part of its attempt to lower drug costs and increase transparency, the US Department of Health and Human Services (HHS) announced a proposed rule on January 31...

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Stemming from the user preference that you set, stay informed and increase your productivity via 27/7 web based access to Ontellitrac and a customized email alert system summarizing the most recent oncology-specific information available.

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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

May 24, 2019

MASCC/ISOO 2019 Annual Meeting (Multinational Association of Supportive Care in Cancer & International Society of Oral Oncology)

San Francisco, CA

June 27, 2019

NCCN Policy Summit: The State of Cancer Care in America: The Impact of State Policy on Access to High-Quality Cancer Care

Washington, DC

June 29 - 30, 2019

The 7th International Conference On Advances In Hematology & Oncology (ICAHO19) - ASCO® 2019 Annual Meeting Review (Binaytara Foundation)

Seattle, WA

July 12, 2019

NCCN Policy Summit: Defining and Applying Quality in an Evolving Health Policy Landscape and the Implications for Cancer Care

Washington, DC

September 12 - 14, 2019

12th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved

San Francisco, CA

September 25 - 28, 2019

OBR Radar

Top 5 Market Moving Events

Date	Company and Product
May 24	Incyte Corp., Jakafi® (ruxolitinib) Incyte said on Feb. 7, 2019 that the FDA had extended the review period for the sNDA for ruxolitinib for the treatment of patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids, a Breakthrough Therapy indication. The new PDUFA target action date is May 24, 2019. The sNDA submission is based on data from the REACH1 study. Topline results from the ongoing trial demonstrated an overall response rate (ORR) of 55% (n=39/71) at Day 28, the primary endpoint. In addition, the best overall response rate was 73% (n=52/71). If approved, ruxolitinib, a first-in-class JAK1/JAK2 inhibitor already approved for several other indications, will be the first and only treatment available to U.S. patients with acute GVHD who have not responded adequately to corticosteroid therapy. The FDA granted Breakthrough Therapy and Orphan Drug designations to ruxolitinib in the indication.
Jun 10	Merck , Keytruda® (pembrolizumab) Merck announced on Feb. 11, 2019 that the FDA had accepted and granted a Priority Review to its sBLA for Keytruda as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The application is based in part on data from the pivotal phase 3 KEYNOTE-048 trial where pembrolizumab demonstrated a significant improvement in overall survival (OS) compared with the standard of care, as monotherapy in patients whose tumors expressed PD-L1 with CPS≥20 and CPS≥1 and in combination with chemotherapy in the total patient population. The data were presented at ESMO 2018. The PDUFA, or target action date, is June 10, 2019.
Jun 17	Merck & Co., Keytruda® (pembrolizumab) Merck announced on Feb. 20, 2019 that the FDA had accepted and granted a Priority Review to a new sBLA for Keytruda as monotherapy for the treatment of patients with advanced small cell lung cancer (SCLC) whose disease has progressed after two or more lines of prior therapy. Merck is seeking accelerated approval for the new indication, based on data from the SCLC cohorts of the phase 2 KEYNOTE-158 and phase 1b KEYNOTE-028 trials. The FDA has set a PDUFA, or target action, date of June 17, 2019. The five-year survival rate for SCLC is only 6% overall, Merck said in a press release, stressing the need for significant new treatment options for the disease. It's the first U.S. application for pembrolizumab in SCLC. Keytruda is being studied in combination with chemotherapy in the ongoing phase 3 KEYNOTE-604 study in patients with newly diagnosed extensive stage SCLC.
Jun 27	Celgene Corp., Revlimid® (lenalidomide) Celgene announced on Feb. 26, 2019 that the FDA had granted a Priority Review to the company’s sNDA for Revlimid in combination with rituximab (R²) for the treatment of patients with previously treated follicular and marginal zone lymphoma. The FDA has set its action, or PDUFA, date as June 27, 2019. The sNDA is based on results from the phase 3 AUGMENT study, which evaluated the efficacy and safety of the investigational R² combination versus rituximab plus placebo in patients with relapsed/refractory follicular and marginal zone lymphoma. The study's results were presented at the 2018 ASH annual meeting. Revlimid alone or in combination with other agents is not approved for use in follicular lymphoma or marginal zone lymphoma anywhere globally.
Jun 30	Pfizer , PF-06439535 (proposed biosimilar to bevacizumab) In August 2018, the FDA accepted for review a BLA for PF-06439535, Pfizer's proposed biosimilar to Avastin. Pfizer said in its third quarter earnings 2018 press release on Oct. 30, 2018 that the expected Biosimilar User Fee Act (BsUFA) goal date for a decision by the FDA is second-quarter 2019.