On May 9, 2019 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported the launch of a generic version of Tarceva1 (erlotinib) tablets, 100 and 150 mg, in the U.S (Press release, Teva, MAY 9, 2019, View Source [SID1234536093]).

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Erlotinib Tablets are a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Erlotinib Tablets are also indicated for first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine.

"The launch of generic Tarceva tablets marks an important addition to our offering of oncology products," said Brendan O’Grady, EVP and Head of North America Commercial.

With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in eight generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

Tarceva tablets have annual sales of $202 million in the U.S., according to IQVIA data as of February 2019.

About Erlotinib Tablets

Erlotinib Tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Limitations of use: Safety and efficacy of Erlotinib Tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. Erlotinib Tablets are not recommended for use in combination with platinum-based chemotherapy.

Erlotinib Tablets in combination with gemcitabine are indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

IMPORTANT SAFETY INFORMATION

Cases of serious interstitial lung disease, including fatal cases, can occur with erlotinib treatment. Hepatorenal syndrome, severe acute renal failure including fatal cases, and renal insufficiency can occur with erlotinib treatment. Renal failure may arise from exacerbation of underlying baseline hepatic impairment or severe dehydration. Hepatic failure and hepatorenal syndrome, including fatal cases, can occur with erlotinib treatment in patients with normal hepatic function; the risk of hepatic toxicity is increased in patients with baseline hepatic impairment.

Gastrointestinal perforation, including fatal cases, can occur with erlotinib treatment. Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease may be at increased risk of perforation. Bullous, blistering and exfoliative skin conditions, including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal, can occur with erlotinib treatment. The risk of cerebrovascular accident is increased in patients with pancreatic cancer. The risk of microangiopathic hemolytic anemia is increased in patients with pancreatic cancer.

Decreased tear production, abnormal eyelash growth, keratoconjunctivitis sicca or keratitis can occur with erlotinib treatment and can lead to corneal perforation or ulceration. Severe and fatal hemorrhage associated with International Normalized Ratio (INR) elevations can occur when erlotinib and warfarin are administered concurrently. Based on animal data and its mechanism of action, erlotinib can cause fetal harm when administered to a pregnant woman.

The most common adverse reactions (≥ 20%) with erlotinib from a pooled analysis in patients with NSCLC across all approved lines of therapy, with and without EGFR mutations, and in patients with pancreatic cancer were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting.

For more information, please see accompanying Full Prescribing Information. A copy may be requested from Teva U.S. Medical Information at 888-TEVA-USA (888-838-2872), [email protected], or Teva’s Public Relations or Investor Relations contacts.