This week, the FDA granted approval to Roche’s (RHHBY - Free Report) tumor-agnostic medicine, Rozlytrek (entrectinib), and J&J’s (JNJ - Free Report) tuberculosis tablet Sirturo for adolescent patients. Meanwhile, Lilly (LLY - Free Report) and AstraZeneca (AZN - Free Report) announced data from studies on psoriasis drug Taltz and cancer drugs Tagrisso and Lynparza, respectively.
Recap of the Week’s Most Important Stories
Roche’s Personalized Medicine Rozlytrek Gets FDA Nod: The FDA granted approval to Roche’s personalized medicine Rozlytrek (entrectinib) for patients with ROS1-positive, metastatic non-small cell lung cancer (NSCLC) and neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumors. Per Roche, Rozlytrek is the first tumour-agnostic medicine to be approved in the United States that selectively targets both ROS1 and NTRK fusions. Rozlytrek has also shown responses in these two rare types of cancer that have spread to the brain. Japan was the first country to grant approval to Rozlytrek in June.
J&J’s Sirturo Gets FDA-Approved for Young TB Patients: J&J’s pulmonary multidrug-resistant tuberculosis tablet Sirturo (bedaquiline) was approved by the FDA for the treatment of adolescent patients (12 to less than 18 years of age and weighing at least 30 kgs). The drug is already approved for use in adults and is being evaluated in a phase II pediatric research and development program in different age groups.
Lilly’s Taltz Shows Superiority Over J&J’s Tremfya: Lilly announced top-line data from a phase IV IXORA-R study, a head-to-head comparison between its plaque psoriasis drug Taltz and J&J’s new drug, Tremfya (guselkumab). Data from the study demonstrated that Taltz helps more plaque psoriasis patients achieve 100% skin clearance compared to Tremfya at week 12. This was measured by the proportion of patients who achieve complete skin clearance, in other words, 100% improvement from their baseline as measured by Psoriasis Area Severity Index (PASI) 100 score — the study’s primary endpoint.
AstraZeneca Tagrisso Improves Overall Survival in First-Line Study: AstraZeneca’s Tagrisso significantly improved overall survival (OS) in the phase III FLAURA study for first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR mutations. Tagrisso was approved for this indication based on progression free survival (PFS) data from the same study in the United States and EU in 2018. OS was the secondary endpoint in the study and AstraZeneca expects to present this data at an upcoming medical meeting.
A phase III study (PAOLA-1) evaluating AstraZeneca and Merck’s (MRK - Free Report) PARP inhibitor, Lynparza, for a broader advanced ovarian cancer patient population met the primary endpoint. The study evaluated Lynpazra as a first-line maintenance treatment in combination with Roche’s Avastin (bevacizumab) versus Avastin alone in women with advanced ovarian cancer with or without BRCA gene mutations. Data from the study showed that treatment with Lynparza plus Avastin led to a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) in the intent-to-treat (ITT) population versus Avastin alone. Lynparza is presently approved as first-line maintenance treatment in BRCAm advanced ovarian cancer following response to platinum-based chemotherapy.
Meanwhile, the FDA granted Breakthrough Therapy Designation (BTD) to Calquence for chronic lymphocytic leukemia (CLL) as a monotherapy treatment. Calquence is presently marketed for previously-treated mantle cell lymphoma (MCL). However, AstraZeneca expects to file regulatory applications for Calquence to get approval for the CLL indication (in frontline and the relapsed/recurrent disease setting), which includes a much larger patient population base, later this year.
The NYSE ARCA Pharmaceutical Index declined 2.2% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions.
All the stocks were in the red last week expect AstraZeneca (0.1%). Pfizer (PFE - Free Report) saw the steepest decline (6.4%)
In the past six months, AstraZeneca has been the biggest gainer (8.0%) while Pfizer declined the most (18.6%).
(See the last pharma stock roundup here: AGN, NVO Earnings, EU Nod to SNY & ABBV Drugs for New Patients)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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