OBR – News, Perspective, Catalyst

Today's Oncology News

Opt In Search Archives

Roche's Tecentriq Cocktail Scores Trial Success In Mela...

(Reuters) Dec 13, 2019 - A late-stage clinical trial has shown therapy combining Roche’s immunotherapy Tecentriq with two of its other drugs...

Transgene Reports on the Combination Trial of TG4010, C...

(Morningstar) Dec 12, 2019 - Transgene, a biotech company that designs and develops virus-based immunotherapeutics against cancer, today annou...

BeiGene Announces Clinical Data on Investigational Anti...

(BeiGene) Dec 13, 2019 - BeiGene, Ltd. and Mirati Therapeutics today announced preliminary data from an ongoing Phase 1b trial of investigatio...

Senate OKs Trump's FDA Nominee Despite Unclear Vaping A...

(NBC News/Associated Press) Dec 12, 2019 - The Senate on Thursday confirmed Dr. Stephen Hahn to lead the Food and Drug Administration despite ...

Featured Content

Jasmine Zain, MD, considers how peripheral T-cell lymphoma therapy has evolved in recent years

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center and Bradley Monk, MD, FACOG, FACS, Professor and Director of the Division of Gynecologic Oncology at Creighton University School of Medicine, discuss ovarian cancer clinical updates from ESMO 19

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center and Marwan Fakih, MD, Professor, Department of Medical Oncology & Therapeutics Research, City of Hope, discuss colorectal cancer clinical updates from ESMO 19

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center and Geoffry R. Oxnard, MD, Associate Professor of Medicine, Associate Professor of Medicine, Dana Farber Cancer Instituate, Harvard Medical School, discuss integrating liquid biopsies into lung cancer care

Artificial intelligence (AI) has the potential to identify patients with cancer at high risk of unplanned utilization of acute care, a critical healthcare cost driver. OBR spoke with Cardinal Health’s Amy Valley, PharmD, on the opportunities and obstacles to implementing AI in identification of these high-risk patients.

Patient-reported outcomes (PROs) monitoring has been shown to have multiple benefits for cancer patients, while also representing an important tool for providers in implementing value-based care. We look at some of the steps needed to integrate PROs effectively and seamlessly into the electronic workflow and routine cancer care.

Podcasts

Lung Cancer – Geoffrey Oxnard, MD, and Robert Figlin, MD, discuss integrating liquid biopsies into lung cancer care

00:00

Listen on
Apple Podcasts

Listen on
Google Play

Listen on
Spotify

Title

Released

Colorectal Cancer – Marwan Fakih, MD, and Robert Figlin, MD, provide post ESMO ’19 clinical update

10/28/19

Ovarian Cancer – Bradley Monk, MD, and Robert Figlin, MD, provide post ESMO ’19 clinical update

10/10/19

Colorectal Cancer (CRC) - Scott Kopetz, MD, and Robert Figlin, MD, provide post World GI '19 clinical update

07/30/19

Hepatocellular carcinoma (HCC) - Daneng Li, MD and Robert Figlin, MD, discuss clinical highlights from ASCO 2019

07/02/19

Expert Video Insights

Search by

David Andorsky, MD, discusses the implications of real-world evidence for oncologists

Kylee Martens, MD, compares rasburicase versus allopurinol in patients with hyperuricemia

OBR Green

View Archives

November 2019 Edition

Patient-reported outcomes (PROs) monitoring has been shown to have multiple benefits for cancer patients, while also representing an important tool for providers in implementing value-bas...

November 2019 Edition

Artificial intelligence (AI) has the potential to identify patients with cancer at high risk of unplanned utilization of acute care, a critical healthcare cost driver. OBR spoke with Card...

Blog

What to Look for at ASH 2019

Nov 26, 2019

During a pre-meeting webinar devoted to ASH 2019, experts highlighted important advances and practice-changing studies to be presented in Orlando, FL, December 7-...

Third-Line Treatment in Metastatic Colorectal Cancer Po...

Oct 07, 2019

Targeted oral tyrosine kinase inhibitors (TKIs) have an established role in third-line treatment of metastatic colorectal cancer (mCRC), but an expert outlined an...

ESMO Opens with Survival Benefits from Long-Term Data i...

Sep 30, 2019

The 2019 European Society of Medical Oncology (ESMO) opened with a series of trials with positive overall survival (OS) data. Generally considered the gold standa...

OBR Tools

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.

Learn More

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.

Learn More

Oncology Events Calendar

December 17, 2019

Oncologic Drugs Advisory Committee (ODAC) Meeting re: AstraZeneca's sNDA for Lynparza in pancreatic cancer

Silver Spring, MD

December 17, 2019

Oncologic Drugs Advisory Committee (ODAC) Meeting re: Merck's sBLA for Keytruda in bladder cancer

Silver Spring, MD

December 18, 2019

The Latest Developments Reported at the 42nd Annual San Antonio Breast Cancer Symposium (SABCS) (CancerCare Connect® Education Workshop)

[by phone or online via webcast]

December 18, 2019

OBR Radar

Top 5 Market Moving Events

Date	Company and Product
Dec 17	AstraZeneca PLC , Lynparza® (olaparib) During the morning session on Dec. 17, 2019, the FDA's Oncologic Drugs Advisory Committee (ODAC) will review the sNDA for Lynparza,, submitted by AstraZeneca. The proposed indication is for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic adenocarcinoma of the pancreas whose disease has not progressed on first-line platinum-based chemotherapy.
Dec 17	Merck , Keytruda® (pembrolizumab) Although it was first approved in 2014, it's the first time that Merck's PD-1 inhibitor Keytruda will be subjected to an ODAC meeting review scheduled on Dec. 17, 2019. The FDA advisory panel will review data for the sBLA, which was granted a priority review, for the potential use of Keytruda in patients with high-risk non-muscle invasive bladder cancer (NMIBC) that’s unresponsive to standard-of-care Bacillus Calmette-Guérin (BCG) therapy. Merck expects an FDA decision on the indication by Jan. 2020. (See our Jan. 31, 2020 entry also.)
Dec 18	Epizyme , tazemetostat On Dec. 18, 2019 Epizyme will make its case to the FDA's Oncologic Drugs Advisory Committee (ODAC) for the accelerated approval of its oral, first-in-class EZH2 inhibitor tazemetostat as the first drug approved to treat epithelioid sarcoma. The proposed indication for tazemetostat is for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. The FDA granted the NDA a Priority Review with a PDUFA, or target action date, of Jan. 23, 2020. The company's NDA submission is based primarily on data from the 62 patient epithelioid sarcoma cohort of an ongoing phase 2 study. (See our Jan. 23, 2020 entry also.)
Dec 31	AstraZeneca / Merck and Co., Lynparza® (olaparib) + Avastin® (bevacizumab) In announcing positive topline results on June 27, 2018 from the phase 3 SOLO-1 trial of Lynparza, the companies added that the PARP inhibitor is also being investigated in the PAOLA-1 phase 3 trial. That study is evaluating the PARP inhibitor Lynparza in combination with Roche's Avastin as a first-line maintenance treatment in women with newly-diagnosed advanced ovarian cancer regardless of their BRCA status. Detailed results from the highly anticipated PAOLA-1 study are scheduled for presentation at ESMO 2019 on Saturday, Sept. 28, along with several other pivotal trial readouts from competing PARP inhibitors in front-line ovarian cancer. An FDA decision in the indication is expected in the second half of 2019.
Dec 31	Astellas Pharma / Pfizer , Xtandi® (enzalutamide) The companies said on Aug. 21, 2019 that the FDA had accepted for review the sNDA for Xtandi for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC). The application has also been granted Priority Review. Xtandi is currently approved in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC). The submission is based on results from the phase 3 ARCHES trial, which evaluated the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus ADT plus placebo in men with mHSPC. The primary endpoint of radiographic progression-free survival (rPFS) was met in that study. The submission is further supported by data from ENZAMET, an Astellas-backed, investigator-sponsored phase 3 trial. The primary endpoint of overall survival (OS) was met in that study. The FDA has set a PDUFA date, or target action date, in Q4 2019.

OBR Finance

Top 5 Winners

	Last	Change	% △
CTIC	$1.53	0.32	+26.45%
MACK	$4.52	0.78	+20.86%
CLVS	$13.43	1.71	+14.59%
NYMX	$2.26	0.26	+13.00%
GLYC	$6.16	0.59	+10.59%

Top 5 Losers

	Last	Change	% △
SPPI	$8.70	-1.30	-13.00%
VSTM	$1.36	-0.08	-5.56%
BLUE	$84.05	-2.92	-3.36%
CRIS	$1.53	-0.05	-3.16%
LBIO	$5.69	-0.16	-2.74%

Today's Oncology News

Featured Content

Podcasts

Expert Video Insights

OBR Green

Blog

OBR Tools

Sponsored Content

Oncology Events Calendar

Oncologic Drugs Advisory Committee (ODAC) Meeting re: AstraZeneca's sNDA for Lynparza in pancreatic cancer

Oncologic Drugs Advisory Committee (ODAC) Meeting re: Merck's sBLA for Keytruda in bladder cancer

The Latest Developments Reported at the 42nd Annual San Antonio Breast Cancer Symposium (SABCS) (CancerCare Connect® Education Workshop)

Oncologic Drugs Advisory Committee (ODAC) Meeting re: Epizyme's NDA for tazemetostat in epithelioid sarcoma

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

NRG Oncology Semiannual Meeting

38th Annual J.P. Morgan Healthcare Conference

26th ACE Annual Meeting (Association of Cancer Executives)

2020 Gastrointestinal Cancers Symposium (GI 2020) (co-sponsors: AGA, ASCO, ASTRO & SSO)

ASCO-SITC Clinical Immuno-Oncology Symposium

2020 Genitourinary Cancers Symposium (GU 2020) (co-sponsors: ASCO, ASTRO & SUO)

2020 Multidisciplinary Head and Neck Cancers Symposium (ASCO, ASTRO & SITC)

ACCC 46th Annual Meeting & Cancer Center Business Summit

The Annual Assembly of Hospice and Palliative Care 2020 (AAHPM & HPNA)

5th St. Gallen International Gastrointestinal Cancer Conference (EORTC)

NCCN Annual Conference: Improving the Quality, Effectiveness, and Efficiency of Cancer Care™

17th Annual Indy Hematology Review

SWOG Spring Group Meeting 2020

AACR Annual Meeting 2020

2020 ASCO Annual Meeting

NRG Oncology Semiannual Meeting

SWOG Fall Group Meeting 2020

ACCC 37th National Oncology Conference

OBR Radar

Editorial Board Comments

OBR Finance