February 22, 2021
On February 22, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc for the first-line treatment of advanced non-small cell lung cancer (NSCLC) in patients whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK, or ROS1 aberrations.
Read the FDA announcement .
Read the Sanofi announcement.
Posted 2/22/2021
February 16, 2021
On February 16, 2021, G1 Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved "trilaciclib for injection to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). It is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy."
Read the full company announcement .
Read the FDA announcement .
Posted 2/16/2021
February 11, 2021
On February 11, 2021, InsideHealthPolicy announced that hospitals across the United States have asked the Supreme Court "to take up their lawsuits against the Trump administration’s Medicare Part B reimbursement cuts for 340B drugs and pay cuts for outpatient clinic visits at certain off-campus hospital facilities, alleging the U.S. Court of Appeals for the District of Columbia Circuit gave too much weight to the U.S. Department of Health and Human Services' interpretation of the statute in each situation."
Read more on this at InsideHealthPolicy .
Posted 2/11/2021
February 10, 2021
On February 9, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions.
The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.
Read the FDA announcement .
Posted 2/10/21
February 10, 2021
On February 9, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to cemiplimab-rwlc for patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate and granted accelerated approval to cemiplimab-rwlc for patients with metastatic basal cell carxinoma previously treated with a HHI or for whom a HHI is not appropriate.
Read the FDA announcement .
Read Sanofi and Regeneron's announcements.
Posted 2/10/21
February 8, 2021
On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
Read the FDA announcement .
Read the Bristol Myers Squibb announcement .
Posted 2/8/2021
February 8, 2021
On February 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to umbralisib for the following indications:
Read the FDA announcement .
Read TG Therapeutics' announcement .
Posted 2/8/2021
February 4, 2021
On February 3, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib for adult patients with metastatic non-small cell lung cancer (NSCLC) barboring mesenchymal-epithelial transition exon 14 skipping alterations.
This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Read the FDA announcement .
Read Merck KGaA's announcement .
Posted 2/4/21
January 22, 2021
On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).
Read Bristol Myers Squibb's announcement .
Read the FDA announcement .
Posted 1/22/2021
January 22, 2021
On January 22, 2021, the National Comprehensive Cancer Network (NCCN) released new information providing guidance to cancer care providers for vaccinating people with cancer against COVID-19. The NCCN COVID-19 Vaccine Committee recommends that all people currently in active cancer treatment be vaccinated, with considerations regarding immunosuppression and timing. The committee will also meet regularly to update the released recommendations and new recommendations, as they arise.
Read the full NCCN: Cancer and COVID-19 Vaccination recommendations and find more NCCN resources on its COVID-19 Resources web page .
Posted 1/21/2021
January 19, 2021
On January 15, 2021, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.
Read the FDA announcement .
Read Daiichi Sankyo's announcement .
Posted 1/19/2021
January 5, 2021
The Centers for Medicare and Medicaid Services (CMS) released the C-code C9369 (injection, belantamab mafodontin-blmf, 0.5 mg) for GlaxoSmitheKline's Blenrep (belantamab mafodotin-blmf), effective January 1, 2021.
Posted 1/5/2021
December 21, 2020
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent.
Read the FDA announcement .
Read AstraZeneca's announcement .
Posted 12/21/2020
December 21, 2020
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved relugolix for the treatment of adult patients with advanced prostate cancer. It is the first and only oral gonadotropin-releasing hormone receptor antagonist for men with advanced prostate cancer.
Read the FDA announcement .
Read Myovant Sciences' announcement .
Posted 12/21/2020
December 21, 2020
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior
therapy. Selinexor was previously approved under the FDA's accelerated approval program for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Read the FDA announcement .
Read Karyopharm Therapeutics' announcement .
Posted 12/21/2020
December 19, 2020
On December 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. The FDA has determined that the vaccine has met the statutory criteria for issuance of an EUA.
Read the FDA announcement .
Posted 12/18/2020
December 18, 2020
On December 17, 2020, the U.S. Food and Drug Administration (FDA) approved Amgen's rituximab biosimilar Riabni™ (rituximab-arrx), which references Rituxan® (rituximab) and is indicated for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
Read Amgen's announcement .
Posted 12/18/2020
December 17, 2020
On December 16, 2020, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
Read the FDA announcement .
Read MacroGenics' announcement .
Posted 12/17/2020
December 12, 2020
On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows Pfizer and BioNTech's COVID-19 vaccine to be distributed in the United States. The FDA has determined that the vaccine has met the statutory criteria for issuance of an EUA.
For more information on the FDA's emergency use authorization, read the FDA announcement .
Posted 12/12/20
December 3, 2020
The Centers for Medicare & Medicaid Services (CMS) announced its intent to delay the Radiation Oncology (RO) Model to July 1, 2021. The delay is included in the 2021 Hospital Outpatient Prospective Payment (OPPS) Final Rule (CMS-1736-FC) as an interim final rule with a comment period.
Due to the delay, the following changes have been made to the RO Model:
An updated version of the RO Model FAQs to reflect these changes is available.
RO Model Billing Webinar Update
This webinar has also been postponed to Jan. 13, 2021. Call in information for this webinar can be found here .
For any questions not answered in this update, you can reach out via email to CMS at: radiationtherapy@cms.hhs.gov. Additional information about the RO Model, including all changes, can be found on its website .
Posted 12/3/2020
December 2, 2020
On December 1, 2020, the U.S. Food and Drug Administration (FDA) approved pralsetinib for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Read the FDA announcement .
Read Genentech's announcement .
Posted 12/2/2020
December 1, 2020
On December 1, 2020, the U.S. Food and Drug Administration (FDA) approved Gallium 68 PSMA-11 (Ga 68 PSMA-11)—the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.
Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis (when cancer cells spread from the place where they first formed to another part of the body) who are potentially curable by surgery or radiation therapy. Ga 68 PSMA-11 is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels. Ga 68 PSMA-11 is a radioactive diagnostic agent that is administered in the form of an intravenous injection.
Read the FDA announcement .
Posted 12/1/2020
December 1, 2020
On November 30, 2020, Moderna announced that it has submitted an emergency use authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate mRNA-1273. Additionally, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Thursday, December 17.
The company shared that the primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 based on 196 cases confirms the high efficacy observed at the first interim analysis. The point estimate performed indicates a vaccine efficacy of 94.1 percent. Efficacy was consistent across age, race, ethnicity, and gender demographics.
Moderna anticipates that the shipping of mRNA-1273 to designated distribution points throughout the U.S. will occur shortly after an EUA is granted.
Read Moderna's press release . You can find out more on Moderna's COVID-19 vaccine candidate from the Wall Street Journal , New York Times , and Bloomberg .
Posted 12/1/2020
December 1, 2020
The Centers for Medicare & Medicaid Services (CMS) has released resources and reminders to help those participating in the Radiation Oncology (RO) Model. These resources include help with accessing and navigating the Radiation Oncology Administrative Portal (ROAP).
Upcoming Changes to the ROAP:
If you haven't already done so, CMS encourages you to register for ROAP as soon as possible. To register for ROAP, you will need your Model ID, Taxpayer Identification Number (TIN) for physician group practices and freestanding radiation therapy centers or CMS Certification Number (CCN) for Hospital Outpatient Departments, first name, last name, and email address of the designated primary contact in the appropriate fields.
If you do not know your Model ID, please contact the CMS Helpdesk (1.888.734.6433, option 5). Hospital Outpatient Departments should email or call with their CMS Certification Number (CCN), so it can provide the correct Model ID; physician group practices and freestanding radiation therapy centers should call the Helpdesk with their practice’s Taxpayer Identification Number (TIN) to retrieve the correct Model ID.
ROAP Office Hours
RO participants can call into standing office hours that have been set up for troubleshooting ROAP login issues. Office hour dates and times include:
More dates are to be determined after Dec. 3, 2020. To join an office hour, join the Zoom meeting by following the link or by entering the Meeting ID (160 189 1276) and password (881584) on Zoom.
For additional information about the RO Model, please visit its website . Or read the ROAP User Manua l and ROAP FAQs .
Posted 12/1/2020