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Google’s AI Improves Accuracy of Lung Cancer Diag...

(STAT) May 20, 2019 - One of lung cancer’s most lethal attributes is its ability to trick radiologists. Some nodules appear threatening but ...

U.S. District Court Rules Dana-Farber Scientist is an I...

(Associated Press) May 17, 2019 - The U. S. District Court ruled today that a Dana-Farber Cancer Institute scientist, Gordon Freeman, PhD, and...

‘This Terrible Disease’: Ovarian Cancer Is ...

(Washington Post) May 18, 2019 - Compared with other cancer success stories, the disease historically has had a shortage of good news. Until r...

A Rare Genetic Mutation Leads to Cancer. The Fix May Al...

(New York Times) May 17, 2019 - A common dietary supplement may help overcome mutations in the Pten gene. Should patients take it? When Kel...

Featured Content

Jeff Patton, MD, considers whether OneOncology is open to growth in new markets

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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Robin Shah regarding the capabilities of OneAnalytics

Nicholas Vogelzang, MD, FASCO, FACP, regarding the evolution of ADT in prostate cancer

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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...

OBR Tools

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Oncology Events Calendar

May 23, 2019

Coping with the Stresses of Caregiving When Your Loved One Has Multiple Myeloma

[by phone or online via webcast]

May 24, 2019

Living with Advanced Skin Cancer – Emerging Treatments for Metastatic Melanoma (CancerCare Connect® Education Workshop)

[by phone or online via webcast]

May 31- June 4, 2019

2019 ASCO Annual Meeting

Chicago, IL

June 5 - 7, 2019

2019 AOSW 35th Annual Conference (Association of Oncology Social Work)

Tucson, AZ

June 6, 2019

ACCC Oncology Reimbursement Meeting | Oregon

Portland, OR

June 13 - 16, 2019

24th Congress of EHA (European Hematology Association)

RAI Amsterdam, The Netherlands

June 15 - 21, 2019

EORTC-ESMO-ECCO-AACR Methods in Clinical Cancer Research

Zeist, Netherlands

June 18 - 22, 2019

International Conference on Malignant Lymphoma (ICML)

Lugano, Switzerland

June 21 - 23, 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

FDA-ASCO Public Workshop: 2019 Clinical Outcome Assessments in Cancer Clinical Trials

Silver Spring, MD

July 12, 2019

ASCO Direct™ Highlights – Hawaii

Honolulu, HI

July 19 - 20, 2019

2019 Best of ASCO Bellevue on Seattle’s Eastside

Bellevue, WA

July 19 - 22, 2019

Immune Cell Therapies for Cancer: Successes and Challenges of CAR T Cells and Other Forms of Adoptive Therapy

San Francisco, CA

July 19, 2019

ASCO Direct™ Highlights – New York

New York, NY

July 26 - 27, 2019

2019 Best of ASCO Austin

Austin, TX

July 27 - August 2, 2019

ASCO/AACR Methods in Clinical Cancer Research Workshop

Vail, CO

August 2 - 3, 2019

2019 Best of ASCO Baltimore

Baltimore, MD

August 10, 2019

ASCO Direct™ Highlights – South Carolina

Charleston, SC

September 5, 2019

2019 ASCO Oncology Practice Conference

San Diego, CA

September 6 - 7, 2019

ASCO Quality Care Symposium

San Diego, CA

September 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

ECCO 2019 European Cancer Summit

Brussels, Belgium

September 15 - 18, 2019

2019 ASTRO Annual Meeting

Chicago, IL

September 20 - 22, 2019

13th Annual Conference of the International Liver Cancer Association (ILCA 2019)

Chicago, IL

September 20 - 23, 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

Fifth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival

Paris, France

September 27 - 28, 2019

NCCN 2019 Annual Congress: Hematologic Malignancies™

San Francisco, CA

September 27 - October 1, 2019

ESMO 2019 Congress

Barcelona, Spain

October 17 - 18, 2019

8th InterAmerican Oncology Conference: Current Status and Future of Anti-Cancer Therapies

Buenos Aires, Argentina

October 25 - 26, 2019

Supportive Care in Oncology Symposium (ASCO)

San Francisco, CA

October 26 - 30, 2019

AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Boston, MA

October 30 - November 1, 2019

ACCC 36th National Oncology Conference

Orlando, FL

November 6 - 10, 2019

34th Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer (SITC 2019)

National Harbor, MD

November 7 - 10, 2019

10th Annual Navigation & Survivorship Conference (Academy of Oncology Nurse & Patient Navigators)

Nashville, TN

December 10 - 14, 2019

San Antonio Breast Cancer Symposium

San Antonio, TX

December 11, 2019

NCCN Patient Advocacy Summit: Delivering Value for Patients across the Oncology Ecosystem

Washington, DC

January 9 - 12, 2020

Advancing Precision Medicine Drug Development: Incorporation of Real World Data and Other Novel Strategies

San Diego, CA

January 22 – 24, 2020

26th ACE Annual Meeting (Association of Cancer Executives)

New Orleans, LA

January 23 - 25, 2020

ASCO Gastrointestinal Cancers Symposium

San Francisco, CA

February 13 - 15, 2020

ASCO Genitourinary Cancers Symposium

San Francisco, CA

February 27 - 29, 2020

2020 Multidisciplinary Head and Neck Cancers Symposium

Scottsdale, AZ

March 4 – 6, 2020

ACCC 46th Annual Meeting & Cancer Center Business Summit

Washington, D.C.

April 24 - 29, 2020

AACR Annual Meeting 2020

San Diego, CA

May 29 - June 2, 2020

2020 ASCO Annual Meeting

Chicago, IL

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.