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

FDA Approves TECENTRIQ® (atezolizumab) for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer

TECENTRIQ in combination with paclitaxel protein-bound* is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1–stained tumor-infiltrating immune cells [IC] of any intensity covering ≥1% of the tumor area), as determined by an FDA-approved test.

This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). *Paclitaxel protein-bound is also referred to as nab-paclitaxel (nab-pac).

Also Genentech is excited to share the news of a new 840 mg vial and new FDA-approved indication for a Genentech therapy. TECENTRIQ® (atezolizumab) is now available in a new 840 mg single-dose vial and has a new dosing schedule.

Please see the attached TECENTRIQ 840 mg Now Available Flashcard, as well as the TECENTRIQ full Prescribing Information, for additional Important Safety Information.

Full Prescribing Information:

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

TECENTRIQ Flashcard

New FDA Approval for KEYTRUDA®

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

KEYTRUDA is also indicated for the treatment of patients with unresectable or metastatic melanoma.

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

FDA=Food and Drug Administration; PD-L1=programmed death ligand 1.

KEYTRUDA® (pembrolizumab) Prescribing Information

The Medication Guide also is available.

UDENYCA™ (pegfilgrastim-cbqv) Q-code Assigned

On November 21, 2018 CMS released their HCPCS Quarterly Update. Included in that update was a new Q-code for  UDENYCA™ (pegfilgrastim-cbqv):

HCPCS Code     Long Descriptor

Q5111           Injection, Pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg.

For More Information on billing UDENYCA™ go to: 

www.coheruscomplete.com

Oncotype DX(R) AR-V7 Nucleus Detect(TM) Test - Favorable Draft LCD

Epic Sciences and Genomic Health Announce Favorable Draft Local Coverage Determination (LCD) on Medicare Coverage for Use of the Oncotype DX(R) AR-V7 Nucleus Detect(TM) Test in Patients with Metastatic Castration-Resistant Prostate Cancer.

Medicare Draft Coverage Supports Clinical Utility of the Oncotype DX AR-V7 Nucleus Detect Test, Providing 25,000 Medicare Patients with Coverage Once LCD Is Finalized Epic Sciences, Inc. (Epic) and Genomic Health, Inc. (Nasdaq: GHDX) announced today that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a draft local coverage determination (LCD) for the Oncotype DX® AR-V7 Nucleus Detect™ test. The draft LCD recommends Medicare coverage for use of the test throughout the United States to help determine which patients with metastatic castration-resistant prostate cancer (mCRPC) may benefit from androgen receptor signaling inhibitor (ARSi) therapy and which may benefit from chemotherapy. The Oncotype DX AR-V7 Nucleus Detect test is a circulating tumor cell (CTC)-based, liquid biopsy test that is commercially available in the United States through Epic's partnership with Genomic Health.  


"The Oncotype DX AR-V7 Nucleus Detect test is the first and only predictive and prognostic test in prostate cancer that can identify which patients will no longer benefit from ARSi therapies, such as enzalutamide and abiraterone, and need to switch to chemotherapy or start another type of therapy in order to extend life," said Murali Prahalad, Ph.D., president and CEO of Epic Sciences. "The rapid issuance of the draft LCD recommending Medicare coverage highlights the clinical utility and value of this new test in prolonging survival for men with metastatic castration-resistant prostate cancer."