FDA Approves Genentech?s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer
? Tecentriq?s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall ?
? Approval based on the Phase III IMpower110 study showing Tecentriq demonstrated a significant overall survival benefit in people with high PD-L1 expression compared with chemotherapy ?
May 18, 2020 03:30 PM Eastern Daylight Time
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq??(atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained = 50% of tumor cells [TC = 50%] or PD-L1 stained tumor-infiltrating [IC] covering = 10% of the tumor area [IC = 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
?We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,? said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. ?Today marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease.? This approval is based on an interim analysis from the Phase III IMpower110 study, which showed Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.59, 95% CI: 0.40?0.89; p=0.0106) in people with high PD-L1 expression (TC3/IC3-wild-type [WT]). Safety for Tecentriq appeared to be consistent with its known safety profile, and no new safety signals were identified. Grade 3?4 treatment-related adverse events (AEs) were reported in 12.9% of people receiving Tecentriq compared with 44.1% of people receiving chemotherapy. Tecentriq is the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks. The supplemental Biologics License Application for the Tecentriq monotherapy was granted Priority Review, a designation given to medicines the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. In the U.S., Tecentriq has received four approvals across NSCLC, including as a single agent or in combination with targeted therapies and/or chemotherapies. It is also approved in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adults with extensive-stage small cell lung cancer. Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines. About the IMpower110 study IMpower110 is a Phase III, randomized, open-label study evaluating the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in PD-L1-selected, chemotherapy-na?ve participants with stage IV non-squamous or squamous NSCLC. The study enrolled 572 people, of whom 554 were in the intention-to-treat WT population, which excluded people with EGFR or ALK genomic tumor aberrations, and were randomized 1:1 to receive:?We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions?
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- Tecentriq monotherapy, until disease progression (or loss of clinical benefit, as assessed by the investigator), unacceptable toxicity or death; or
- Cisplatin or carboplatin (per investigator discretion) combined with either pemetrexed (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.
- Tecentriq may be used alone as their first treatment when their lung cancer:
- has spread or grown,?and
- their cancer tests positive for ?high PD-L1?,?and
- their tumor does not have an abnormal ?EGFR? or ?ALK? gene
- Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer:
- has spread or grown,?and
- is a type called ?non-squamous NSCLC,??and
- their tumor does not have an abnormal ?EGFR? or ?ALK? gene
- Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer:
- has spread or grown,?and
- is a type called ?non-squamous NSCLC,??and
- their tumor does not have an abnormal ?EGFR? or ?ALK? gene
- Tecentriq may also be used when their lung cancer:
- has spread or grown,?and
- they have tried chemotherapy that contains platinum, and it did not work or is no longer working.
- if their tumor has an abnormal ?EGFR? or ?ALK? gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working
- Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as their first treatment when their lung cancer:
- is a type called ?extensive-stage small cell lung cancer,? which means that it has spread or grown
- Lung problems (pneumonitis)?signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain
- Liver problems (hepatitis)?signs and symptoms of hepatitis may include yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual
- Intestinal problems (colitis)?signs and symptoms of colitis may include?diarrhea (loose stools) or more bowel movements than usual,?blood or mucus in stools or dark, tarry, sticky stools,?and severe stomach area (abdomen) pain or tenderness
- Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary)?signs and symptoms that the hormone glands are not working properly may include headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness), feeling cold, constipation, voice gets deeper, urinating more often than usual, nausea or vomiting, and stomach area (abdomen) pain
- Problems in other organs?signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
- Severe infections?signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating, and frequent urination or back pain
- Severe infusion reactions?signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of the face or lips, dizziness, fever, feeling like passing out, and back or neck pain
- have immune system problems (such as Crohn?s disease, ulcerative colitis, or lupus); have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects the nervous system (such as myasthenia gravis or Guillain-Barre syndrome); or are being treated for an infection
- are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq.?Females who are able to become pregnant:
- A healthcare provider should do a pregnancy test before they start treatment with Tecentriq
- They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
- are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq
- feeling tired and weak
- nausea
- cough
- shortness of breath
- decreased appetite
- feeling tired and weak
- nausea
- hair loss
- constipation
- diarrhea
- decreased appetite