March 24, 2022
On March 23, 2022, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.
Read the FDA announcement .
Read Novartis' announcement .
Posted 3/24/2022
March 22, 2022
On March 21, 2022, the U.S. Food and Drug Administration (FDA) approved pembrolizumab as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
Read the FDA announcement .
Read Merck's announcement .
Posted 3/22/2022
March 21, 2022
On March 18, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
Read the FDA announcement .
Read Bristol Myers Squibb's announcement .
Posted 3/21/2022
March 17, 2022
On Thursday, March 17, 2022, the U.S. Food and Drug Administration (FDA) approved the FoundationOne ® CDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR tyrosine kinase inhibitors that are approved by FDA for this indication.
Read Foundation Medicine's announcement .
Posted 3/17/2022
March 14, 2022
On March 11, 2022, the U.S. Food and Drug Administration (FDA) approved Myriad Genetics, Inc.'s BRACAnalysis ® CDx test for use as a companion diagnostic to identify patients with germline BRCA-mutated (gRBCAm) human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early-stage breast cancer who may benefit from Lynparza ® (olaparib) (AstraZeneca).
Read the Myriad Genetics, Inc. announcement .
Posted 3/14/2022
March 14, 2022
On Friday, March 11, 2022, the U.S. Food and Drug Administration (FDA) approved olaparib for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
Read the FDA announcement .
Read AstraZeneca's announcement .
Posted 3/14/2022
March 1, 2022
On Monday, February 28, 2022, the U.S. Food and Drug Administration (FDA) approved pacritinib for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 9 /L.
Read CTI Biopharma's announcement .
Posted 3/1/2022
March 1, 2022
On Monday, February 28, 2022, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel for the treatment of adults with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Read Janssen's announcement .
Posted 3/1/2022
February 23, 2022
On February 16, 2022, the American Cancer Society's National Consortium for Cancer Screening and Care (ACS National Consortium) announced new cancer screening recommendations to accelerate recovery from the COVID-19 pandemic. These recommendations also look to improve the United States' ability to provide quality cancer screening and care for all.
The nine consensus recommendations include themes on:
Read the full list and details of the recommendations on the ACS website .
February 22, 2022
Foundation Medicine, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) for the FoundationOne ® CDx to be used as a companion diagnostic to identify patients with microsatellite instability high (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s Keytruda ® (pembrolizumab).
Read the Foundation Medicine announcement .
Posted 2/22/2022
February 14, 2022
Starting today, February 14, 2022, Tibsovo ® (ivosidenib tablets) will use NDC number 72694-0617-6 for ordering. Though the product packing has changed, Servier ensures the product and ordering process remain the same.
For more information, visit the Tibsovo website .
Posted 2/14/2022
January 26, 2022
On Wednesday, January 26, 2022, the U.S. Food and Drug Administration (FDA) approved tebentafusp-tebn for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Read Immunocore's announcement .
Posted 1/26/2022
December 20, 2021
On December 20, 2021, the U.S. Food and Drug Administration (FDA) approved Illuccix ® , a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, which is a radioactive diagnostic agent indicated for positron emission tomography of prostate-specific membrane antigen positive lesions in patients with prostate cancer with:
For more information, read Telix Pharmaceuticals' announcement .
December 16, 2021
GlaxoSmithKline (GSK) launched its new campaign Target the Future to address the current challenges patients with multiple myeloma and healthcare providers face. This campaign will provide education, identify key challenges the multiple myeloma community faces, and facilitate solutions to create a better future for patients, caregivers, and loved ones.
A component of this campaign is the Target the Future Think Tank Challenge , which is now accepting idea submissions. The winner will receive a $100,000 grant to bring their idea to life.
For more information on this campaign and how you can get involved, read GSK's announcement .
Posted 12/16/2021
December 10, 2021
On December 9, 2021, the U.S. Food and Drug Administration (FDA) granted premarket approval to Oncomine Dx Target Test as a companion diagnostic (CDx) to help identify patients with non-small cell lung cancer whose tumors carry epidermal growth factor receptor Exon20-insertion mutations for potential treatment with Rybrevant ® (amivantamab-vmjw).
Read ThermoFisher Scientific's announcement .
Posted 12/10/2021
December 9, 2021
On December 3, 2021, the Centers for Medicare and Medicaid Services (CMS) released a new data snapshot , featuring telemedicine utilization data that make the case for expanded and permanent telehealth coverage for Medicare beneficiaries.
These data are about people with Medicare who used telemedicine services between March 1, 2020, and February 8, 2021, and they come from Medicare Fee-for-Service data, Medicare Advantage encounter data, and Medicare enrollment information.
CMS states that the agency has seen large increases in telemedicine use during the defined time frame with variations across geographic and demographic groups. This increase is credited to the agency's expansion of telemedicine services during the COVID-19 public health emergency.
The snapshot shows that telemedicine utilization (e.g., telehealth, e-visits, and virtual check-ins) increased from 910,490 unique users pre-pandemic to 28,255,180 unique users during the pandemic. And the majority (53%) of the pandemic's telemedicine users were Medicare beneficiaries. To see a detailed breakdown of these data, read the full snapshot report .
For more information on Medicare's telemedicine expansions, visit its dedicated telehealth website .
Posted 12/9/2021
December 8, 2021
On December 8, 2021, the U.S. Food and Drug Administration (FDA) approved FoundationOne ® CDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, which includes BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations.
Read the Foundation Medicine announcement .
Posted 12/8/2021
December 6, 2021
LeanTaaS will be hosting its Transform Hospital Operations Virtual Summit, which will feature a keynote address from Dr. Scott Gottlieb, from December 7 to 8. This event is hosted in partnership with Becker's Healthcare .
Health system executives, technology leaders, and industry experts will be brought together to discuss solutions for current pressing issues for health systems, such as backlog challenges, staffing shortages and burnout, as increased patient wait times.
Registration is free for all attendees. Go online to view the event's agenda and to register.
Posted 12/6/2021
December 6, 2021
On December 2, 2021, the U.S. Food and Drug Administration approved rituximab in combination with chemotherapy for pediatric patients (greater than or equal to 6 months to less than 18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.
Read the FDA announcement .
Posted 12/6/2021
December 6, 2021
On December 3, 2021, the U.S. Food and Drug Administration approved Keytruda ® (pembrolizumab) for the adjuvant treatment of adult and pediatric (greater than or equal to 12 years of age) patients with stage IIB or IIC melanoma following complete resection.
Read the FDA announcement .
Read Merck's announcement .
Posted 12/6/2021
December 2, 2021
On November 30, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received one to three prior lines of therapy.
Read the FDA announcement .
Read Janssen, Inc.'s announcement .
Posted 12/2/2021
November 30, 2021
The Center for Medicare & Medicaid Innovation (CMS Innovation Center) announced an update to its special roundtable discussion. This roundtable will discuss how the CMS Innovation Center can execute its strategic objective to advance health equity.
The roundtable is scheduled for Wednesday, December 8, 2021, from 1:30 to 3:00 PM EST. To participate, register online .
Learn more about this roundtable and the CMS Innovation Center's objective in advancing health equity by reading its recently published white paper and visiting its website.
Posted 11/30/2021
November 30, 2021
On November 29, 2021, the U.S. Food and Drug Administration (FDA) approved pafolacianine, an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery.
Read the FDA announcement .
Read On Target Laboratories, Inc.'s announcement .
Posted 11/20/2021
November 23, 2021
On Novemeber 23, 2021, the U.S. Food and Drug Administration (FDA) approved sirolimus protein-bound particles for injectable suspension (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Read Aadi Bioscience, Inc.'s announcement .
Posted 11/23/2021