OBR – News, Perspective, Catalyst

Today's Oncology News

Opt In Search Archives

Hurricane Disasters Associated With Poorer Outcomes For...

(American Cancer Society) July 12, 2019 - Lung cancer patients who had a hurricane disaster declared during radiotherapy had worse overall sur...

By Targeting Each Patient's Unique Tumor, Precision Med...

(Newsweek Magazine) July 16, 2019 - For tens of thousands of patients, precision medicine is rewriting their cancer stories. Linda Boyed, ...

NICE U-Turn For Kisqali In Breast Cancer

(PharmaTimes [UK]) July 17, 2019 - NICE has recommended Novartis’ Kisqali just three months after its initial rejection. The National In...

Featured Content

Che-Kai Tsao, MD, offers opinion on the results of the ENZAMET study in mHSPC

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center and Edward Garon, MD, Associate Professor of Medicine, Geffen School of Medicine at UCLA, discuss lung cancer highlights from ASCO 2019.

At ASCO, a symposium delved into the ever-expanding importance of real-world data. Several presentations covered the use of RWD to broaden trial eligibility or identify outcomes. There are still hurdles, i.e., improving data collection and interoperability, but good progress is being made.

Oncologists may have more control than we actually think in terms of keeping drug costs down without compromising quality of care. We report on studies from ASCO '19 that look at innovative ways for physicians to get involved. Take a look at what happened at ASCO’s Town Hall on Drug Pricing too.

Podcasts

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

00:00

Listen on
Apple Podcasts

Listen on
Google Play

Listen on
Spotify

Title

Released

Breast Cancer – Neelima Denduluri, MD, and Robert Figlin, MD, discuss clinical highlights from ASCO 2019

06/21/19

Pancreatic Cancer – Vincent Chung, MD, and Robert Figlin, MD, discuss clinical highlights from ASCO 2019

06/21/19

Lung Cancer - Edward Garon, MD, and Robert Figlin, MD, discuss clinical highlights from ASCO 2019

06/21/19

Urothelial Cancer - Bradley McGregor, MD, and Robert Figlin, MD, discuss clinical highlights from ASCO 2019

06/21/19

Expert Video Insights

Search by

Marwan G. Fakih, MD, describes the role of KRAS inhibitors in colorectal cancer

Andrew Goy, MD, elaborates on the most exciting recent clinical advances in lymphoma

OBR Green

View Archives

July 2019 Edition

Oncologists may have more control than we actually think in terms of keeping drug costs down without compromising quality of care. We report on studies from ASCO '19 that look at innovati...

July 2019 Edition

At ASCO, a symposium delved into the ever-expanding importance of real-world data. Several presentations covered the use of RWD to broaden trial eligibility or identify outcomes. There ar...

Blog

Rapid Integration of Information Presented at 2019 ASCO...

Jul 15, 2019

Introduction OBR and MDoutlook are pleased to share excerpts from the most recent MDoutlook OncoPolls™ following this year’s ASCO annual meeting in ...

Targeting Driver Mutations in mNSCLC: Impact of 2019 A...

Jul 11, 2019

Introduction OBR and MDoutlook are pleased to share more excerpts from the most recent MDoutlook OncoPolls™ following this year’s ASCO annual meetin...

nmCRPC and mHSPC: Immediate Impact of 2019 ASCO Annual...

Jul 08, 2019

Introduction OBR and MD Outlook are pleased to share excerpts from the most recent MDoutlook’s OncoPolls™ from his year’s ASCO annual meeting in Chi...

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

July 19 - 20, 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
Aug 03	Daiichi Sankyo , pexidartinib An Oncologic Drugs Advisory Committee (ODAC) voted 12-3 in favor of the approval of Daiichi Sankyo's pexidartinib as a treatment for the symptomatic tenosynovial giant cell tumor (TGCT) in a morning session on May 14, 2019. TGCT is a rare, non-cancerous tumor associated with severe morbidity or functional limitations, which is not amenable to improvement with surgery. The panel however supported strategies that the company proposed to mitigate the risk associated with pexidartinib, including educating healthcare providers about monitoring changes and modifying drug dosage as prescribed. The company said that pexidartinib would be distributed only through specialty pharmacies and both wholesalers and pharmacies would have to complete a certification process in order to dispense the therapy. If approved by the FDA, pexidartinib would be the first and only approved therapy for TGCT. ASCO selected pexidartinib as one of five significant advancements in rare disease treatment in its latest "Clinical Cancer Advances" report. The PDUFA action date of the therapy is Aug. 3, 2019.
Aug 18	Roche , entrectinib (RXDX-101) Roche announced on Feb. 18, 2019 that the FDA had granted a Priority Review to its personalized lung cancer medicine entrectinib, a selective tyrosine kinase inhibitor being developed for non-small cell lung cancer (NSCLC) patients whose tumours carry NTRK fusions or ROS1 fusions. The company said in a press release that "[entrectinib] can potentially target a range of hard-to-treat and rare NTRK fusion-positive tumours regardless of their site of origin, as well as treat ROS1-positive NSCLC." While Pfizer’s Xalkori is already approved to treat patients with ROS1 mutations (in addition to ALK+ patients), entrectinib looks superior since it passes through the blood brain barrier and may prevent brain metastases. The company is also developing a companion diagnostic to help identify people with ROS1 and NTRK gene fusions with Foundation Medicine. Then NDAs are based on results from the integrated analysis of the pivotal phase 2 STARTRK-2, phase 1 STARTRK-1 and phase 1 ALKA-372-001 trials, and data from patients from the phase 1/1b STARTRK-NG study of pediatric patients. The FDA is expected to make an approval decision by August 18, 2019.
Sep 02	Roche , Tecentriq® (atezolizumab) + Abraxane® + carboplatin Roche announced on Jan. 17, 2019 that the FDA had accepted the company’s sBLA for Tecentriq in combination with chemotherapy (Abraxane) and (carboplatin) for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations. The FDA is expected to make an approval decision by September 2, 2019. The sBLA is based on results from the phase 3 IMpower130 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS).
Sep 30	Pfizer , PF-05280586 (proposed biosimilar to rituximab) In September 2018, the FDA accepted for review a BLA for PF-05280586, a proposed biosimilar to Rituxan/MabThera. 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 third-quarter 2019.
Oct 24	GlaxoSmithKline plc / Tesaro, Zejula® (niraparib) GSK announced on June 24, 2019 Tesaro, its oncology-focused business unit, submitted a supplemental New Drug Application (sNDA) to the FDA for Zejula. The sNDA supports a potential new indication for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with either 1) BRCA mutation or 2) homologous recombination deficiency (HRD) and has progressed more than six months after the last platinum-based chemotherapy. The niraparib sNDA is supported by data from the phase 2 QUADRA trial. The application has priority review with an action date of Oct. 24, 2019.