Invitation to Best of ASCO in Bellevue

ASCO and WSMOS cordially invite you to join us for the 2019 Best of ASCO® Meetings, which showcase the scientific and educational highlights from the world’s premier oncology event, the ASCO Annual Meeting. 

This year’s Presidential theme, developed by Dr. Monica Bertagnolli, is Caring for Every Patient, Learning from Every Patient. Every patient deserves equal access to the highest quality care and the opportunity to participate in research. 

Condensed into two days of in-depth analysis and discussion, attendees will discover the latest science to bring back to their clinics, attend sessions that integrate trending topics in oncology, and interact with top faculty. Register and reserve your hotel at boa.asco.org

New FDA Approval for VENCLEXTA® (venetoclax tablets)

On May 15, 2019, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

VENCLEXTA is also approved in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

VENCLEXTA Access Solutions is your resource for access and reimbursement support after VENCLEXTA is prescribed. VENCLEXTA Access Solutions can help your patients and practice by providing:

  • Benefits investigations (BIs)
  • Prior authorization (PA) resources
  • Information about authorized specialty pharmacies (SPs) and specialty   distributors
  • Sample billing and coding information
  • Resources for denials and appeals
  • Patient assistance options

A list of authorized SPs and specialty distributors is available at Genentech-Access.com/VENCLEXTA.

Please see full Prescribing Information for Indication and additional Important Safety Information.

Venclexta Billing and Coding

FDA Approves First-line Combination Rx for Advanced RCC

On May 14, 2019 Pfizer announced that the FDA has approved BAVENCIO® (avelumab) in combination with INLYTA® (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Resources:

Press Release

For prescribing information for BAVENCIO® and INLYTA®: https://www.bavencio.com/hcp 

KEYTRUDA Receives New FDA Approval

Merck is pleased to announce that KEYTRUDA, in combination with axitinib, has been approved by the FDA for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

·    PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information.

The Medication Guide also is available.

Read the entire Press Release Here

New FDA Approval for KADCYLA

On May 3, 2019, the FDA approved ado-trastuzumab emtansine (KADCYLA, Genentech, Inc.) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

More Information:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ado-trastuzumab-emtansine-early-breast-cancer

Full Prescribing Information:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125427s105lbl.pdf 

KEYTRUDA Receives New FDA Approval

Merck is pleased to announce that KEYTRUDA, as a single agent, has been approved by the FDA for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

·    PD-L1 diagnostic testing is required prior to initiating treatment with KEYTRUDA in these patients

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving

KEYTRUDABefore prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information

The Medication Guide also is available.

IBRANCE® (palbociclib) Indications Now Include Male Patients

Pfizer Oncology is proud to announce that the indications for IBRANCE® (palbociclib) now include male patients as shown below:

IBRANCE is indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with:

  • an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men, or
  • fulvestrant in patients with disease progression following endocrine therapy

Based on limited data from post-marketing reports and electronic health records, the safety profile for men treated with IBRANCE is consistent with the safety profile in women treated with IBRANCE. The recommended dosing regimen is also consistent for male and female patients.

For patients requiring financial assistance, Pfizer Oncology has support programs that may be able to help. You can learn more at the product website IBRANCEhcp.com.

Full updated prescribing information is available here.

FDA Approves TECENTRIQ® (atezolizumab) for first-line (1L) treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Tecentriq Patient Assistance & Reimbursement Information:

https://www.tecentriq-hcp.com/small-cell-lung-cancer.html

Full Prescribing Information:

https://www.gene.com/download/pdf/tecentriq_prescribing.pdf