Complete Story
 

12/12/2018

New First-Line Indication for a Genentech Therapy

Genentech is excited to share the news of a new FDA-approved indication. TECENTRIQ® (atezolizumab), in combination with Avastin® (bevacizumab), paclitaxel, and carboplatin, is now indicated for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (nsqNSCLC) with no EGFR or ALK genomic tumor aberrations.

Please see the attached TECENTRIQ 1L NSCLC Day 1 Letter, as well as the TECENTRIQ full Prescribing Information, for additional Important Safety Information. Please forward to relevant stakeholders or departments in your organization.

Genentech BioOncology® Access Solutions offers a range of access and reimbursement support to help patients begin treatment as soon as possible. We can help your patients 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

For more information about Genentech BioOncology Access Solutions, please contact me directly, visit

https://www.genentech-access.com/hcp/brands/tecentriq.html or call (888) 249-4918.

 

IMPORTANT SAFETY INFORMATION

Serious Adverse Reactions

Please refer to the full Prescribing Information for important dose management information specific to adverse reactions.

  • Immune-mediated pneumonitis. Immune-mediated pneumonitis or interstitial lung disease, including fatalcases, have occurred. Permanently discontinue TECENTRIQ for Grade 3 or 4 pneumonitis
  • Immune-mediated hepatitis. Immune-mediated hepatitis and liver test abnormalities, including fatal cases, have occurred. Permanently discontinue TECENTRIQ for AST or ALT elevations more than 8 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal
  • Immune-mediated colitis. Immune-mediated diarrhea or colitis have occurred. Permanently discontinue TECENTRIQ for Grade 4 diarrhea or colitis
  • Immune-mediated endocrinopathies. Thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus, including diabetic ketoacidosis, and hypophysitis/hypopituitarism have occurred
  • Other immune-mediated adverse reactions. TECENTRIQ can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system. Permanently discontinue TECENTRIQ for Grade 4 immune-mediated adverse reactions involving a major organ
  • Infections. Severe infections, including fatal cases, have occurred
  • Infusion-related reactions. Severe or life-threatening infusion-related reactions have occurred. Permanently discontinue TECENTRIQ in patients with Grade 3 or 4 infusion-related reactions
  • Embryo-fetal toxicity. TECENTRIQ can cause fetal harm in pregnant women. Verify pregnancy status prior to initiating TECENTRIQ. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose
  • Advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose

Most Common Adverse Reactions

The most common adverse reactions (rate ≥20%) in patients receiving TECENTRIQ with bevacizumab, paclitaxel, and carboplatin for previously untreated NSCLC were fatigue/asthenia (50%), alopecia (48%), nausea (39%),

diarrhea (32%), constipation (30%), decreased appetite (29%), arthralgia (26%), hypertension (25%), and peripheral neuropathy (24%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report

side effects to Genentech at 1-888-835-2555.

Please see accompanying full Prescribing Information for additional Important Safety Information or go to

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

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