TSRO – TESARO, Inc. Investigation on Behalf of TSRO Investors

TSRO – TESARO, Inc. Update to VARUBI® (rolapitant) U.S. Prescribing Information – TSRO Stock Falls During Intraday Trading

(NASDAQ:TSRO)

Kehoe Law Firm’s investigation concerns whether TESARO and certain of its officers or directors have engaged in securities fraud or other unlawful business practices.

On January 12, 2018, TESARO announced that it had updated the VARUBI® (rolapitant) injectable emulsion package insert in collaboration with the FDA.  The update regarding VARUBI® (rolapitant), indicated for the prevention of delayed nausea and vomiting associated with chemotherapy, resulted from receiving reports of “[a]naphylaxis, anaphylactic shock and other serious hypersensitivity reactions . . . in the postmarketing setting, some requiring hospitalization.”  Further, TESARO stated that TESARO “issued a Dear Healthcare Professional (DHCP) letter,” which, along with the “updated full prescribing information,” is available on the VARUBI website.

TESARO’s share price, on this news, fell sharply during intraday trading on January 16, 2018.

“TESARO Announces Updates to the U.S. Prescribing Information for VARUBI® (rolapitant) Injectable Emulsion”

According to TSRO’s January 12, 2018 announcement:

TESARO . . . an oncology-focused biopharmaceutical company, . . . announced that it has updated the VARUBI® (rolapitant) injectable emulsion package insert in collaboration with the U.S. Food and Drug Administration (FDA). VARUBI injectable emulsion is a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with chemotherapy in adults. The changes to the labeling include modifications to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, and ADVERSE REACTIONS sections.

Following its introduction in late November 2017, TESARO estimates that at least 7,000 doses of VARUBI injectable emulsion have been administered to patients receiving emetogenic chemotherapy in the United States. Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of VARUBI injectable emulsion. Most reactions have occurred within the first few minutes of administration. [Emphasis added]

TSRO’s “Dear Health Care Provider Letter”

TESARO’s Dear Health Care Provider Letter, among other things, stated:

The purpose of this letter is to inform you of important safety information for VARUBI® (rolapitant) injectable emulsion, a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with cancer chemotherapy in adults. 

Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions Associated with Use of VARUBI® (rolapitant) Injectable Emulsion 

Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of VARUBI® (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration. Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock. 

TSRO – TESARO Investors & Shareholders

Kehoe Law Firm, P.C. is investigating whether TESARO and certain of TESARO’s officers or directors engaged in securities fraud or other unlawful business practices.  If you invested in TSRO securities and have questions or concerns about your potential legal rights or claims, please contact John Kehoe, Esq., (215) 792-6676, Ext. 801, [email protected], complete the form above on the right or e-mail [email protected].

Kehoe Law Firm, P.C.