New FDA Approval for KEYTRUDA

Merck is pleased to announce that KEYTRUDA, in combination with platinum and fluorouracil (FU), has been approved by the FDA for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA has also been approved by the FDA as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

PD-L1 diagnostic testing is required prior to initiating monotherapy with KEYTRUDA in patients with metastatic or with unresectable, recurrent HNSCC.

Prior Indication:

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

This prior indication has not changed.

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

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information.
The Medication Guide also is available.

New FDA Approval for KEYTRUDA

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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

Click Here to read the FDA Approval Notice

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

The Medication Guide also is available.

KEYTRUDA (pembrolizumab) Additional Indication

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 [combined positive score (CPS) ≥10] as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

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

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

Click Here to read the FDA Approval Notice. 

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

The Medication Guide also is available.

FDA Grants Accelerated Approval for POLIVY™

On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval for POLIVY™ (polatuzumab vedotin-piiq) in combination with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least 2 prior therapies.

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

·       Benefits investigations (BIs)

·       Prior authorization (PA) resources

·       Information about authorized specialty distributors

·       Sample billing and coding information

·       Resources for appeals

·       Referrals to co-pay support

·       Patient assistance options

 

A list of authorized specialty distributors is available at Genentech-Access.com/POLIVY

Resources:

Prescribing Information

Sample Coding Brochure

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Inlyta® (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC)

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

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

CLICK HERE to read the Merck Press Release

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information
The Medication Guide also is available.

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