Announcing a New First-Line Indication for a Genentech Therapy
- Katrina Williams
- March 22, 2019
- No responses
Genentech is excited to share the news of a new FDA-approved indication. TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line (1L) treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Please see the attached TECENTRIQ 1L SCLC 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.
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 fatal cases, 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 females of reproductive potential 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
Most Common Adverse Reactions
The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ in combination with other antineoplastic drugs for NSCLC and SCLC were fatigue/asthenia (49%), nausea (38%), alopecia (35%), constipation (29%), diarrhea (28%), and decreased appetite (27%).
You may report side effects to the FDA at 1-800-FDA-1088 orwww.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.