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FDA Approves Luspatercept-aamt for Anemia In Adults Wit...

(FDA.gov) Apr 6, 2020 - On April 3, 2020, the Food and Drug Administration approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the ...

Immunomedics Announces ASCENT Study to be Stopped for C...

(Immunomedics) Apr 6, 2020 - Decision based on recommendation from DSMC following study data review. Sacituzumab govitecan has the potential ...

Merck Receives Priority Review from FDA for Second Appl...

(Merck) Apr 7, 2020 - Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FD...

Karyopharm to Evaluate Low Dose Selinexor as a Potentia...

(Karyopharm) Apr 7, 2020 - Karyopharm Therapeutics Inc. today announced plans to initiate a global randomized clinical trial for low dose oral...

Cancer Surgeries and Organ Transplants Are Being Put Of...

(ProPublica) Apr 6, 2020 - In a given month, more than a million people have some kind of surgery. The elective procedures being postponed bec...

Featured Content

Bradley McGregor, MD, shares presented data investigating atezolizumab and cabozantinib in metastatic castration resistant prostate cancer

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center, and Tian Zhang, MD, Assistant Professor of Medicine, Duke University School of Medicine, discuss the progress in RCC presented at ASCO GU '20

Community oncology practices like Florida Cancer Specialists & Research Institute (FCS) and OneOncology have started rapidly implementing changes in hope of mitigating the spread of the novel coronavirus among their already vulnerable patient population. OBR spoke to providers at both practices about their concerns and to find out what steps they're ...

Podcasts

Renal Cell Carcinoma (RCC) – Tian Zhang, MD, and Robert Figlin, MD, discuss recent clinical advances in RCC from ASCO GU

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Prostate Cancer – Daniel Petrylak, MD, and Robert Figlin, MD, discuss recent clinical advances in prostate canc...

03/02/20

Colorectal Cancer – Zev Wainberg MD, and Robert Figlin, MD, discuss recent clinical advances in colorectal canc...

02/12/20

Mantle Cell Lymphoma (MCL) – Michael Wang MD, and Robert Figlin, MD, discuss recent clinical advances in mantle...

02/03/20

Chronic Lymphocytic Leukemia (CLL) – Lori Leslie MD, and Robert Figlin, MD, discuss clinical highlights in the ...

01/10/20

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Bradley McGregor, MD, on impressions of phase I/II study of oral HIF-2 α inhibitor MK-6482 in patients with adv...

Tian Zhang, MD, on the follow up study investigating nivolumab + ipilimumab in 1st line RCC patients

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March 2020 Edition

Community oncology practices like Florida Cancer Specialists & Research Institute (FCS) and OneOncology have started rapidly implementing changes in hope of mitigating the spread of t...

Blog

New Telehealth Policies Ensuring Cancer Patients Aren&r...

Apr 07, 2020

by Ted Okon I don’t have to tell anyone that the novel coronavirus has caused an unprecedented global crisis. However, with attention rightfully so on COVID-...

Dean's Digest - ASCO GU 2020

Feb 19, 2020

Major themes which emerged from ASCO GU 2020 included a plethora of studies utilizing various permutations of targeted therapies along with immunotherapy and/or c...

Dean's Digest - ASCO GI 2020

Jan 28, 2020

ASCO GI 2020 was held in San Francisco January 23-25. Numerous studies involving Phase 1/2 evaluations of new drugs in gastrointestinal (GI) malignancies were rep...

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.

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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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April 8, 2020

For Caregivers: Care Coordination for Your Loved One Living with Cancer and Other Health Problems (CancerCare Connect® Education Workshop)

[by phone or online via webcast]

April 23 - 24, 2020

ISNS 2020 (International Sentinel Node Society’s Biennial Meeting in collaboration with the Society of Surgical Oncology)

Houson, TX

May 15 - 16, 2020

2020 MSK Cardio-Oncology Symposium [CANCELLED; POSTPONED TIL 2021]

New York, NY

May 29 - June 2, 2020

2020 ASCO Annual Meeting [VIRTUAL FORMAT]

[Virtual Format]

June 27, 2020

Memorial Sloan Kettering 2nd Annual Palliative Care Symposium for Advanced Practice Providers [CANCELLED; POSTPOSED TIL 2021]

New York, NY

June 27 - 28, 2020

OBR Radar

Top 5 Market Moving Events

Date	Company and Product
Apr 18	UroGen Pharma Ltd. , UGN-101 (mitomycin gel) The company announced on Dec. 19, 2020 that the FDA had accepted for filing and granted priority review for its NDA for UGN-101 (mitomycin gel) for instillation as a potential treatment for patients with low-grade upper tract urothelial cancer (LG UTUC). If approved, UGN-101 would be the first non-surgical treatment option for LG UTUC. The company said in a press release that there is a significant unmet need for a better treatment option for patients with LG UTUC since the current standard of care involves surgical removal of the kidney or repetitive endoscopic tumor removal. The FDA assigned a PDUFA action date of April 18, 2020 to the application. The NDA is supported by positive results from the pivotal, single-arm phase 3 OLYMPUS trial enrolling 74 patients in the U.S. and Israel. Results from a final analysis of the primary endpoint showed that UGN-101 demonstrated a complete response rate of 59% in patients with LG UTUC. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of LG UTUC.
Apr 30	Pfizer , Braftovi® (encorafenib) + Erbitux® (cetuximab) (BRAFTOVI Doublet) Pfizer said on Dec. 18, 2019 that the FDA had accepted and granted a priority review to its sNDA for Braftovi in combination with Erbitux in a form of colorectal cancer. The agency set a target action date in April 2020. The company said the designation covers the combination in patients with advanced BRAF(V600E)-mutant metastatic colorectal cancer, following one or two lines of therapy. Pfizer said the designation is based on the phase 3 BEACON CRC trial that evaluated the efficacy and safety of the combination with or without Mektovi® (binimetinib) and showed improvements in overall survival and objective response rates for both compared to Erbitux plus irinotecan-containing regimens.
May 14	Blueprint Medicines , Ayvakit™ (avapritinib) The company announced on Feb. 6, 2020 that the FDA had extended its PDUFA action date by three months from Feb. 14, 2020 to May 14, 2020 for its NDA seeking accelerated approval of avapritinib for the treatment of adults with fourth-line gastrointestinal stromal tumor (GIST). The FDA cited its request for top-line data from Blueprint Medicines' ongoing phase 3 VOYAGER clinical trial, comparing avapritinib to regorafenib in third- or fourth-line GIST, as the reason for the extension. Blueprint expects to submit the data early in the second quarter of 2020. Ayvakit, a kinase inhibitor, became the first precision therapy FDA approved to treat a genomically defined population of patients with gastrointestinal stromal tumor (GIST) on Jan. 9, 2020. The indication approved by U.S. regulators is for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. The company also said in its Feb. 6 announcement that the NCCN had updated its Clinical Practice Guidelines in Oncology for soft tissue sarcoma to include avapritinib as a recommended category 2A treatment for unresectable or metastatic GIST with a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, as well as fourth-line GIST. The rating indicates that there is uniform NCCN consensus that the intervention is appropriate. Blueprint has a broad clinical development program in place for avapritinib across multiple lines of GIST treatment, in addition to advanced, smoldering and indolent systemic mastocytosis (SM).
May 15	Clovis Oncology, Rubraca® (rucaparib) Clovis Oncology said on Jan. 15, 2020 that the FDA had accepted the company’s sNDA for Rubraca as monotherapy for adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer and granted a Priority Review to the application. The PDUFA action date assigned for an FDA decision is May 15, 2020. The submission is based on data from the Triton clinical program in advanced prostate cancer.
May 15	Bristol-Myers Squibb, Opdivo® (nivolumab) + Yervoy® (ipilimumab) The company said on Jan. 15, 2020 that U.S. regulators had accepted its sBLA for Opdivo in combination with Yervoy for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The FDA granted the application Priority Review with a PDUFA goal date of May 15, 2020. The application is based on data from part 1 of the phase 3 CheckMate -227 trial evaluating Opdivo plus Yervoy vs. chemotherapy in patients with previously untreated NSCLC. The dual immunotherapy combination demonstrated significant improvement in overall survival versus chemotherapy alone in the trial.